BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESTEP HUBER NEEDLE SET 22G X 0.75IN

    MDR report key: 10399086 · Received August 12, 2020

    Report

    Report Number
    3006260740-2020-02912
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 12, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FPA
    UDI-DI
    00801741066160
    PMA / PMN Number
    K153440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF ASDWS0068 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (ASDWS0068) HAVE BEEN REPORTED FROM THE SAME FACILITY IN FRANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTENDER SUDDENLY DISCONNECTED FROM THE HUBER NEEDLE TUBING. IT WAS STATED DISCONNECTION IN HDJ BETWEEN THE "PERFUSION SHAFT" AND THE TUBING OF THE HUBER NEEDLE THE PATIENT ALERTED THE TEAM WHO CHANGED ALL THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860356 SAFESTEP HUBER NEEDLE SET 22G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS N/A ASDWS0068 00801741066160

    Patients

    Seq Age Sex Outcome Treatment
    1