BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFILLED SYRINGE WITH LUER LOCK 0.5 ML

    MDR report key: 4546530 · Received February 19, 2015

    Report

    Report Number
    MW5040905
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    February 13, 2015
    Report Date
    February 19, 2015
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INVOLVES A PRE-FILLED SYRINGE WITH THE FOLLOWING PRODUCT INFO. MEDICATION: HYDROMORPHONE HCL 0.5 MG/0.5 ML, 0.5 ML PRE-FILLED SYRINGE WITH LUER LOCK. MFR: HOSPIRA, INC., NDC # (B)(4), LOT # 46540LL. EXPIRATION DATE: OCTOBER 10, 2016. WHILE ATTEMPTING TO ADMINISTER THIS MEDICINE THE PLUNGER WOULD NOT ADVANCE. THERE WAS EXTREME RESISTANCE AT THE PLUNGER MAKING THE ADMINISTRATION OF THIS NARCOTIC MEDICATION UNSAFE AS IT WOULD REQUIRE AN EXTREMELY FORCEFUL "PUSH" WHICH WOULD DELIVER THE ENTIRE DOSE INSTANTANEOUSLY. PHARMACIST WAS CALLED TO BEDSIDE AND ALLOWED TO WITNESS THIS INCIDENT. DATES OF USE: (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120707 PREFILLED SYRINGE WITH LUER LOCK 0.5 ML SYRINGE FMF HOSPIRA, INC. 46540LL

    Patients

    Seq Age Sex Outcome Treatment
    1