BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML L/L NO NDL

    MDR report key: 10032296 · Received May 6, 2020

    Report

    Report Number
    MW5094403
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Report Date
    April 30, 2020
    Manufacturer
    BD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT INFUSES RUCONEST 2100 UNITS (14ML) TO 4200 UNITS (28ML) BY SLOW INTRAVENOUS INJECTION OVER APPROX 5 MINS TWICE A WEEK AND AS NEEDED BASIS FOR BREAKTHROUGH ATTACKS. F/U CALL OUT TO PT, PT REPORTED THE ONLY ISSUES SHE'S HAVING WITH THE 30ML SYRINGES IS THAT THEY REQUIRE HER TO USE UP TO 3 SYRINGES PER INFUSION BECAUSE SOME ARE BREAKING. SHE WOULD LIKE TO TRY A DIFFERENT MFR OTHER THAN BD WHICH SHE IS HAVING ISSUES WITH. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495000 SYRINGE 30ML L/L NO NDL SYRINGE, PISTON FMF BD

    Patients

    Seq Age Sex Outcome Treatment
    1