BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21GX.75IN. BD VACUTAINER® WINGED SAFETY PBBCS WITH 12 IN TUBING

    MDR report key: 7058784 · Received November 27, 2017

    Report

    Report Number
    1710034-2017-00340
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 27, 2015
    Report Date
    January 24, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    UDI-DI
    00382903673261
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS- ONE UNUSED SAMPLE WAS RETURNED AND THE CUSTOMER'S DEFECT WAS CONFIRMED. CONCLUSIONS- ROOT CAUSE: DUE TO MANUFACTURING. PINCHING OF THE TUBING AT THE HUB LOAD OR THE FRONT BARREL LOAD STATIONS.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITHOUT A 510K NUMBER. THE 510K OF THIS DEVICE IS K030573.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® WINGED SAFETY PBBCS WITH 12 IN. TUBING 21 G X .75 IN TUBE HAD BEEN CUT UPON OPENING THE PACKAGE. NO MEDICAL INTERVENTION/INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838775 21GX.75IN. BD VACUTAINER® WINGED SAFETY PBBCS WITH 12 IN TUBING BLOOD COLLECTION SET JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5064502 00382903673261

    Patients

    Seq Age Sex Outcome Treatment
    1 Other