BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MK SYRINGE 3-P., LL 10CC

    MDR report key: 3854245 · Received May 29, 2014

    Report

    Report Number
    2523676-2014-00205
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Report Date
    May 9, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: "AROUND 3 WEEKS AGO NURSE ATTEMPTED TO DRAW UP DIPRIUM 20CC BOTTLE WITH A 10CC SYRINGE. WHEN SHE INSERTED THE SYRINGE (SHE HAD WITHDRAWN THE PLUNGER ABOUT 4-5CC'S) IT APPEARED THE VACUUM WAS SO HIGH THAT IT BLEW OUT THE BOTTOM OF THE GLASS BOTTLE. IT SHATTERED IN HER HAND. SHE HAD NEVER HAD THIS HAPPEN BEFORE." NO SAMPLE AVAILABLE. MFR - 9610825-2014-00205.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317341 MK SYRINGE 3-P., LL 10CC SYRINGES FMF B. BRAUN MELSUNGEN AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK