BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHRINK SAFE WRAP

    MDR report key: 17799469 · Received September 21, 2023

    Report

    Report Number
    MW5146046
    Event Type
    Other
    Date Received
    September 21, 2023
    Date of Event
    July 6, 2023
    Report Date
    September 19, 2023
    Manufacturer
    UNK
    Product Code
    QMX
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OUR SYSTEM UTILIZES SHRINK WRAP (FROM SHRINK SAFE) ON NEUROMUSCULAR BLOCKER VIALS. WHILE REMOVING SHRINK WRAP ON A ROCURONIUM VIAL, THE PULL TAB BROKE OFF AND LEFT THE VIAL INACCESSIBLE. THIS IS NOT THE FIRST TIME THIS HAS REPORTEDLY HAPPENED. THERE HAVE BEEN CONTINUED AND GROWING CONCERNS WITH THIS STRATEGY TO DIFFERENTIATE NEUROMUSCULAR BLOCKER VIALS AND THE BARRIER COMPONENT HAS PROVED TO BE A DISADVANTAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500542 SHRINK SAFE WRAP LABEL OR TAG, NON-STERILE QMX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown