BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO

    MDR report key: 9675864 · Received February 6, 2020

    Report

    Report Number
    9675864
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 28, 2020
    Report Date
    January 30, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE SMITH MEDICAL SAF-T HOLDER DEVICE THAT IS A BLOOD TRANSFER DEVICE TO A TUBE. THE PLASTIC FREQUENTLY BREAKS OFF. THE BROKEN PIECE IS IN THE BLUE CAP THEN. LOT NUMBER FOR THIS INSTANCE IS 3881692. IT WAS ABUNDANTLY CLEAR IT WAS NOT BECAUSE OF FORCE USED, EVEN GENTLY SCREWING THIS ON THE BLUE PORT, IT BREAKS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138394 JELCO TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA SMITHS MEDICAL ASD, INC. 96000 125138

    Patients

    Seq Age Sex Outcome Treatment
    1