BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 20152465 · Received September 5, 2024

    Report

    Report Number
    1917413-2024-00829
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 2, 2024
    Report Date
    August 19, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    00382903627936
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 4 SAMPLES WERE RECEIVED AT FRANKLIN LAKES AND 7 PHOTOS WERE RECEIVED IN SUPPORT OF THIS COMPLAINT. VISUAL EXAMINATION OF THE SAMPLES AND PHOTOS WAS PERFORMED AND REVEALED COLLAPSE. EVACUATED, PLASTIC BLOOD COLLECTION TUBES WILL COLLAPSE IF SUBJECTED TO ELEVATED TEMPERATURES (IN EXCESS OF APPROXIMATELY 55°C). 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 THE INDICATED FAILURE MODE COLLAPSE. BD WAS UNABLE TO IDENTIFY AN EXACT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 4 TUBES HAD A MOLDING DEFECT (COLLAPSED TUBES). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074873 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 3348614 00382903627936

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown