BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 20076359 · Received August 27, 2024

    Report

    Report Number
    1917413-2024-00779
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 16, 2024
    Report Date
    July 30, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED 100 SAMPLES AND 9 PHOTOS FOR INVESTIGATION. VISUAL EXAMINATION OF THE SAMPLES AND PHOTOS WAS PERFORMED AND REVEALED FOREIGN MATTER (FM) AND SCRATCHES ON THE TUBE AND FM IN THE TUBE. THERE ARE WHITE PARTICLES THAT APPEAR TO BE PLASTIC, A PIECE OF CLEAR TAPE, AND BLACK PARTICLES ON THE INSIDE OF THE TUBE; SCRATCHES ARE ALSO ON THE OUTSIDE OF THE SIDEWALL OF THE TUBE. 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 MODES FM ON THE INSIDE, FM ON THE OUTSIDE, AND DAMAGED PRODUCT (SCRATCHES). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG THERE WAS FOREIGN MATTER(FM) INSIDE AN UNSPECIFIED NUMBER OF TUBES. FM AND SCRATCHES WERE ALSO OBSERVED ON THE OUTSIDE OF THE TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969953 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 3289094 30382903627883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown