Kurin® Blood Culture Collection Set with Kurin Lock® Technology
Instructions for Use
(KUR-4000 Rev H)
The Kurin Blood Culture Collection Set is a sterile, single-use device that includes a vasculature connection (i.e., winged needle, male luer connection), flexible tubing, Kurin Lock, and blood culture bottle holder (when supplied). Upon access to the patient’s vasculature, the Kurin Lock is designed to receive a portion of the initial blood from a patient, propelled by the patient’s own blood pressure, into its side channel thereby enabling blood collection to occur through an adjoining sampling channel with reduced levels of the initial blood being included.
Venipuncture sets incorporate a needle-safe feature that covers the needle prior to disposal to aid in the prevention of needlestick injury if activated after the blood draw.
Various Peripheral IV (PIV) sets incorporate a pressure-rated extension set with slide clamp that, when detached from the blood culture collection set, can be used for infusion purposes.
The blood culture bottle holder varies between device models. Refer to the primary labeling for the compatible culture bottle.
INDICATIONS FOR USE
The Kurin Blood Culture Collection Set is intended to obtain blood samples through the patient’s vasculature via venipuncture or Peripheral IV (PIV) access. As it enters the Kurin Lock, blood initially fills a side channel then flows into the sample collection device (syringe or bottle) via an adjoining sampling channel to reduce blood culture contamination rates*.
When supplied with a pressure-rated extension set, the pressure-rated extension set is intended to be utilized separately with infusions systems to administer IV fluids, medications, blood and blood products into the patient’s vascular system and may be safely used with power injectors at pressures up to 325 psi.
*The Kurin Blood Collection System is for use as a blood collection system and its Kurin Lock allows the specimen of blood from the patient to be sidelined prior to the collection of the test sample to reduce the frequency of blood culture contamination when contaminates are present in the initial blood sample compared to blood cultures drawn using standard practice without the Kurin Lock.
The Kurin Blood Culture Collection Set is to be used for blood collection ONLY. It is not to be used for infusion, IV administration, or transfusion except when supplied with a pressure-rated extension set and the pressure-rated extension set is detached and used separately.
INSTRUCTIONS FOR USE
- Visually inspect the device and packaging to confirm there is no damage (device is not cracked or broken). If the packaging appears to be damaged (punctured, torn) do not use the device.
- Remove device from its packaging.
- Ensure that the blood culture bottle holder, when supplied, and other connections are secure before use. If needed, remove the holder by twisting and pulling the holder to collect the blood specimen using a syringe.
- Vasculature Access
4.1 FOR VENIPUNCTURE SETS:
Remove needle cover. Perform disinfection and venipuncture per hospital protocol.
Caution: Care should be taken to avoid touching the needle.
4.2 FOR PERIPHERAL IV (PIV) SETS:
Perform disinfection and catheter access per hospital protocol. Attach the set’s luer connector to the freshly placed short peripheral catheter.
- Observe the flow of blood into the Kurin Lock side channel. Once blood flow has stopped, the set is ready for blood sample acquisition.
Caution: Do NOT connect the collection vial or culture bottle to the blood culture bottle holder before flow has stopped.
- Perform blood collection using collection vials or culture bottle per hospital protocol. For blood culture bottle holders that include an insert, it can be removed, if necessary, by grasping the outside of the holder with one hand and pulling on the upper rim with the other hand. The insert will separate from the holder.
Caution: Avoid touching the sampling needle in the blood culture bottle holder.
- Completion of Sample Acquisition
7.1 FOR STANDARD NEEDLE SETS:
Withdraw the patient needle by grasping the translucent safety shield grip area with the thumb and index finger. With opposite hand, grasp tubing between thumb and index finger while pushing the safety shield forward until a click is heard indicating the needle is completely retracted and the safety shield is locked in place.
7.2 FOR PUSH BUTTON NEEDLE SETS:
While the needle is in the patient’s vasculature, depress the button. The safety mechanism will engage and lock into place (Do not impede device retraction).
7.3 FOR PERIPHERAL IV (PIV) SETS WITH PRESSURE-RATED EXTENSION SET:
Clamp the extension line with the slide clamp, disconnect the blood culture collection set from the extension set, and then proceed with the setup of the IV line per hospital protocol. Completely prime the extension set by connecting to a primed IV administration set or syringe. Flush the device after each use with flushing syringe. Replace the IV line per hospital protocol.
- After use, dispose of set per hospital protocol.
- Per hospital protocol, use the provided package lid form to track collections.
- Single-use ONLY. Do NOT reuse. Medical devices require specific material characteristics to perform as intended. These characteristics have been verified for single-use only. Reuse of the product may cause harmful infections, injury, or death.
- Read the instructions carefully before using the device.
- Do not use this device after the expiration date has passed.
- Do not use if the device is cracked, broken or tubing is kinked.
- Do not use this device if the packaging is punctured or damaged in any way.
- Blood culture bottle holder must be secure before use. Do not use if holder is not connected.
- Do NOT connect the collection tube or bottle to the blood culture bottle holder until blood has filled the Kurin Lock side chamber and the blood flow has ceased.
- Mishandling of the device may result in a contaminated needlestick, which may cause infectious disease.
- Devices that become contaminated with blood are considered hazardous and must be disposed of immediately after use.
- The pressure-rated extension set supplied with the blood culture collection set is not to exceed a pressure of 325 PSI.
- Follow standard infection control procedures as specified in the appropriate published guidelines.
- When using vacuum tubes, caution should be exercised to ensure the stopper is punctured centrally and that the tubes are not placed into the adapter at an angle.
- Handle all biologic samples and blood collection “sharps” (lancets, needles, luer adapters, and blood collection sets) in accordance with the policies and procedures of your facility. Obtain appropriate medical attention in the event of any exposure to biologic samples (e.g. through a puncture injury) since samples may transmit viral hepatitis, HIV (AIDS), or other infectious diseases. Utilize any built-in used needle protector if the blood collection device provides one. Discard all blood collection “sharps” in biohazard containers approved for their disposal.
- This device is to be used by trained medical professionals only.
FOR PERIPHERAL IV (PIV) SETS:
- Do not use needles, metal/blunt cannulas, non-ISO compliant luers or luer connections with visible defects when accessing the device. Doing so may result in leakage and/or failure of the device. Slip luer connections should not be left unattended due to potential for disconnection.
- For the pressure-rated extension set supplied with the blood culture collection set, ensure catheter patency prior to power injection and verify power injector setting does not exceed the maximum pressure rating of the catheter or tubing sets.
Caution: For product distributed in the USA, federal law restricts this device to sale by or on the order of a physician.
ML-135 Rev B