BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO TRAY WITH SYRINGE

    MDR report key: 8054665 · Received November 9, 2018

    Report

    Report Number
    8054665
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 24, 2018
    Report Date
    November 1, 2018
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OJG
    UDI-DI
    10884389517918
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MD WAS BEGINNING THE SET UP OF A PATIENT'S SHOULDER INJECTION WHEN SHE NOTICED THAT THE SYRINGE USED TO DRAW UP LIDOCAINE WAS CRACKED. THE SAME MD HAD THE SAME THING HAPPEN A WEEK PRIOR WHILE SETTING UP ANOTHER PROCEDURE. ANOTHER MD AT A NEARBY FACILITY ALSO HAD THIS HAPPEN TO HER WITH THE SAME KIT. THE CRACK WAS NOT IDENTIFIED IN THIS INSTANCE AND THE LIDOCAINE SHOT ACROSS THE ROOM. IN THIS EVENT, THE REPORTER OF THIS EVENT HAS SPOKEN TO THE VENDOR AND THE VENDOR CAME TO PICK UP THE SYRINGE AND TO TAKE A LOOK AT IT LAST WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894244 NEURO TRAY WITH SYRINGE NEUROLOGICAL TRAY OJG MEDLINE INDUSTRIES, INC. SPEC0070 2018072450 10884389517918

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA