BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT

    MDR report key: 7059082 · Received November 27, 2017

    Report

    Report Number
    1917413-2017-00221
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    January 25, 2016
    Report Date
    October 30, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    KDT
    UDI-DI
    00382903649464
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS - TWO SAMPLES WERE RECEIVED FROM THE CUSTOMER, EACH SHOWING THE REPORTED DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #5212996. CONCLUSION - THE MECHANICAL TECH WAS INTERVIEWED. HE STATES THE MOST LIKE CASE IS A JAM IN THE AIRWAY THAT TRANSFER THE CUPS OVER. IN ORDER TO CLEAR THE JAM, TECHNICIANS TURN UP THE AIR. DOING SO WILL CAUSE THE CUPS TO HIT THE STOP AND CAUSE CRACKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT CUPS HAVE CRACKS AND/OR HOLES IN THEM. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840584 16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT COLLECTION KIT KDT BECTON, DICKINSON & CO. 5212996 00382903649464

    Patients

    Seq Age Sex Outcome Treatment
    1 Other