BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML L/L NO NEEDLE

    MDR report key: 12481606 · Received September 15, 2021

    Report

    Report Number
    MW5104020
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INDICATION: MYOSITIS, SICCA SYNDROME [SJOGREN]; EVENT: SPONTANEOUS; PATIENT REPORTED LEAKAGE OUT OF 3 SYRINGES WITH REFERENCE NUMBER 1056610, EXPIRATION: 02/28/2026. NO MISSED DOSE; NO ADE REPORTED; UNKNOWN IF AVAILABLE FOR RETURN. NO FURTHER INFORMATION KNOWN. USED TO INFUSE HIZENTRA AT: HIZENTRA 20% (10GM TOTAL) 0.2GM/ML INFUSE 12GM (60ML) SUBCUTANEOUSLY EVERY WEEK. HIZENTRA 20%(2GM TOTAL) 0.2GM/ML INFUSE 12GM (60ML) SUBCUTANEOUSLY EVERY WEEK. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375585 SYRINGE 50ML L/L NO NEEDLE SYRINGE, PISTON FMF BECTON DICKINSON 1056610
    1375586 SYRINGE 50ML L/L NO NEEDLE SYRINGE, PISTON FMF BECTON DICKINSON 1056610
    1375587 SYRINGE 50ML L/L NO NEEDLE SYRINGE, PISTON FMF BECTON DICKINSON 1056610

    Patients

    Seq Age Sex Outcome Treatment
    1