BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 5 ML SYRINGE - LUER-LOK TIP WITH BLUNT FILL NEEDLE

    MDR report key: 4953172 · Received July 24, 2015

    Report

    Report Number
    MW5044910
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    July 4, 2015
    Report Date
    July 24, 2015
    Manufacturer
    BD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    KETAMINE SYRINGES ARE PREPARED AS BATCHES IN (B)(4) PERIODICALLY. ONE OF THE PREFILLED SYRINGES WAS UNABLE TO BE PUSHED THROUGH THE IV. IT HAD TO BE PUSHED EXTREMELY HARD TO GET IT TO GO THROUGH THE IV. THIS COULD HAVE LED TO AN ADVERSE EVENT IF THE DOSE WAS INACCURATELY ADMINISTERED. THIS HAS HAPPENED ON MULTIPLE OCCASIONS REPORTED TO THROUGH THE SAFETY REPORTING SYSTEM (5-6 TIMES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481718 BD 5 ML SYRINGE - LUER-LOK TIP WITH BLUNT FILL NEEDLE SYRINGE FMF BD 5089651

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR MFR: JHP PHARMACEUTICALS.| KETAMINE 200 MG/20ML, LOT #762047, NDC# (B)(4),