BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 3ML SYRINGE

    MDR report key: 17479421 · Received August 7, 2023

    Report

    Report Number
    MW5120693
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 3, 2023
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 3ML SYRINGES DISCOVERED TO BE CRACKED UPON MANIPULATING FOR IV STERILE COMPOUNDS. DEFECT LOT NUMBERS IDENTIFIED: 3103923, 3111336, 3118444 AND 3111348. CRACKED SYRINGES WERE NOT USED TO COMPLETE STERILE COMPOUNDS. REFERENCE REPORTS MW5120694, MW5120695, MW5120696.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013674 BD PLASTIPAK 3ML SYRINGE SYRINGE, PISTON FMF BECTON DICKINSON AND COMPANY 3103923

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown