BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA

    MDR report key: 5027314 · Received August 25, 2015

    Report

    Report Number
    5027314
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    August 2, 2015
    Report Date
    August 12, 2015
    Manufacturer
    BD
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BEHAVIORAL HEALTH PATIENT RESTRAINED AND REQUIRING ATIVAN IM. NEEDLE DID NOT RETRACT AFTER PLUNGER CLICKED, ENTIRE MEDICATION INITIALLY PREPARED WAS NOT FULLY ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560764 INTEGRA SYRINGE FMF BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other