BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE BLOOD COLLECTION TUBES HEPARIN

    MDR report key: 19376924 · Received May 22, 2024

    Report

    Report Number
    1125230-2024-00059
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Report Date
    June 14, 2024
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K960857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. SAMPLES WERE ONLY RECENTLY RECEIVED, AND THEIR EVALUATION IS STILL IN PROGRESS. AS SOON AS THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). NO CUSTOMER SAMPLES WERE RECEIVED FOR EVALUATION. NO ADDITIONAL CUSTOMER PICTURES WERE RECEIVED. NO MATERIAL # WAS PROVIDED. NO BATCH # WAS PROVIDED. SAMPLES FROM REMAINING GBO INVENTORY OF MATERIAL/BATCH 456287P/B2304344, WHICH WAS PREVIOUSLY CLAIMED BY THE CUSTOMER, WERE EVALUATED. SAMPLES WERE TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO CORRECT ASSEMBLY, DRAW VOLUME AND ADDITIVE ACCORDING TO ISO 6710 'SINGLE USE CONTAINERS FOR VENOUS BLOOD SPECIMEN COLLECTION' AND CLSI GP39-A6 REGULATIONS FOR 'EVACUATED TUBES AND ADDITIVES FOR BLOOD SPECIMEN COLLECTION'. TUBES WERE VERIFIED TO BE CORRECTLY ASSEMBLED WITH NO DEVIATIONS OBSERVED. BOTH STANDARDS SPECIFY THE DRAW VOLUME TO BE WITHIN +/- 10% RANGE OF THE NOMINAL FILL VOLUME. NO VISUAL DEVIATION IN FILL VOLUME, SPORADIC LOW OR HIGH FILL, COULD BE OBSERVED IN THE TESTED SAMPLES. ALL TUBES TESTED FILLED WITHIN THE +/-10% TOLERANCE RANGE. ADDITIVE CONTENT WAS FOUND TO BE WITHIN SPECIFICATION IN ALL TESTED SAMPLES. SAMPLES WERE FUNCTIONALLY EVALUATED FOR GEL MOVEMENT (FILLED AND CENTRIFUGED AT 1800G FOR 10MIN - MINIMUM OF RECOMMENDED CONDITIONS). GEL WAS FOUND TO MOVE AND FORM CONSISTENT, EVEN BARRIERS AS INTENDED IN THE TESTED SAMPLES. NO DEVIATION WITH THE FUNCTION OF THE GEL BARRIER COULD BE OBSERVED. SAMPLES WERE EVALUATED IN A BLOOD DRAW FOR THE CLAIMED ISSUE OF GEL ON TUBE WALL. NO GEL ON THE TUBE WALL WAS OBSERVED. ALL TESTED SAMPLES DISPLAYED PROPER GEL MOVEMENT AND BARRIER FORMATION; GOOD SEPARATION WAS OBSERVED WHEN CENTRIFUGING USING RECOMMENDED GBO PARAMETERS. THE ALLEGED MALFUNCTION IS NOT CONFIRMED.

    Description of Event or Problem · 0

    CUSTOMER STATES CONTINUED ISSUES WITH GEL ON THE TUBE WALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769602 VACUETTE BLOOD COLLECTION TUBES HEPARIN EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 456287P B2304344

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown