BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 19951707 · Received August 9, 2024

    Report

    Report Number
    1917413-2024-00728
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 11, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    30382903627883
    PMA / PMN Number
    K972075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 4 PHOTOS AND 1 VIDEO WERE PROVIDED FOR INVESTIGATION. THE PHOTOS/VIDEO WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR PLASMA WAS OBSERVED AS PARTICULATE MATTER CAN BE SEEN FLOATING IN THE PLASMA. GEL SMEARING/ABNORMAL GEL COULD NOT BE OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JULY 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR POOR PLASMA. THIS COMPLAINT IS NOT CONFIRMED FOR GEL SMEARING/ABNORMAL GEL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG DURING VALIDATION AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR PLASMA (PARTICLES IN THE PLASMA) AND GEL ISSUES (UNUSUAL APPEARANCE AND CLUMPS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246846 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 3317893 30382903627883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown