BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100

    MDR report key: 15744887 · Received November 7, 2022

    Report

    Report Number
    1125230-2022-00047
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Report Date
    November 7, 2022
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K960858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT: (B)(4). NO CUSTOMER SAMPLES OF THE CLAIMED BATCH WERE PROVIDED. RECEIVED 1PC 455071P/B220933R (NOT PART OF THE COMPLAINT). RECEIVED CUSTOMER PICTURES. WE HAVE NO FURTHER COMPLAINTS FOR THE MATERIAL/BATCH. A CHECK OF QUALITY AND PRODUCTION RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERRORS. THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER STATES THAT WHILE SWITCHING TUBES, THEY ARE HEARING AIR AND THE TUBE WAS FILLING SLOWER, ALMOST LIKE A BALLOON DEFLATING NOISE. CUSTOMER ADVISED AFTER TUBE WAS CENTRIFUGED, THE SAMPLE WAS HEMOLYZED. PER CUSTOMER NEEDLE/BEVEL DID NOT MOVE WHEN CHANGING TUBES. CUSTOMER IS QUESTIONING IF THERE IS AN ISSUE WITH THE SHEATHING COVERING THE NEEDLE IN THE HUB (HOLDER). CUSTOMER PROVIDED TECHNICAL SERVICE ANSWERS TO THE FOLLOWING QUESTIONS; 1. DO YOU HAVE A RACK OF UNUSED TUBES OF ITEM: 455071P, LOT: B220739M TO RETURN FOR EVALUATION? (UPON YOUR REPLY, I WILL SEND A PREPAID UPS LABEL FOR THE RETURN). ANSWER: NO. 2. DO YOU HAVE ANY UNUSED NEEDLES (10-15 PIECES) OF ITEM: 450062 LOT: 19H10C THAT CAN BE RETURNED FOR EVALUATION? ANSWER: YES. 3. HAVE YOU RECEIVED TRAINING FROM A GREINER PRODUCT SPECIALIST? ANSWER: YES, ALL OF OUR STAFF HAVE COMPLETED THE TRAINING. 4. DURING THIS INCIDENT, HOW LONG WAS THE TOURNIQUET APPLIED FOR? ANSWER: LESS THAN 2 MINUTES. 5. WERE THE SAMPLES CENTRIFUGED WITHIN TWO HOURS OF COLLECTION WHEN APPROPRIATE FOR THE TEST(S) ORDERED? ANSWER: YES. 6. DID THE PHLEBOTOMISTS HOLD THE TUBE IN THE HOLDER WITH THEIR THUMB UNTIL THE TUBE WAS FILLED COMPLETELY AS PER INSTRUCTIONS FOR USE (IFU)? ANSWER: YES. IF THE TUBES AREN'T HELD INTO THE BARREL WE ARE EXPERIENCING THE TUBES POPPING OUT OF THE HOLDER DURING BLOOD DRAWS. 7. PRIOR TO VENIPUNCTURE, WAS THE NEEDLE PROPERLY THREADED IN THE HOLDER ACCORDING TO THE IFU? ANSWER: YES. 8. FOR THE NEEDLES, HAVE YOU NOTICED ANY DAMAGE TO THE RUBBERIZED SHEATH? ANSWER: NO. 9. WAS THE SPECIMEN TUBE ALLOWED TO SIT FOR 30 MINUTES PRIOR TO CENTRIFUGATION? ANSWER: YES. 10. DURING THIS INCIDENT, CAN YOU CONFIRM IF THE TUBES WERE UNDERFILLING? ANSWER: THE SECOND TUBE DID NOT FILL COMPLETELY. THIS IS THE SAME TUBE THAT THE PHLEBOTOMIST HEARD AIR COMING FROM THE BLOOD COLLECTION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212435 VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 455071P B220739M

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown