BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH-FLO SUB-Q SINGLE NEEDLE 24X9MM

    MDR report key: 13061878 · Received December 21, 2021

    Report

    Report Number
    MW5106232
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    December 20, 2021
    Report Date
    December 20, 2021
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
    Product Code
    FPA
    UDI-DI
    55555512409
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT DID NOT GIVE SPECIFIC DATE, BUT IN THE PAST MONTH HE HAD AN EVENT WHERE HIS NORMJECT LUER LOCK 10ML SYRINGE AND RMS HI-FLO 24GX9MM NEEDLE SET, DEFECTIVE AND LEAKED DURING AN INJECTION OF HAEGARDA. HE WAS ABLE TO USE A DIFFERENT SET AND RECEIVE THE FULL DOSE OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948866 HIGH-FLO SUB-Q SINGLE NEEDLE 24X9MM SET, ADMINISTRATION, INTRAVASCULAR FPA REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS 55555512409

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Other HAEGARDA