BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE ++ 1ML L/L NO NEEDL BD

    MDR report key: 12467303 · Received September 13, 2021

    Report

    Report Number
    MW5103909
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Report Date
    May 13, 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: SYSTEMIC INVOLVEMENT OF CONNECTIVE TISSUE UNSPECIFIED. EVENT: PATIENT REPORTED THAT LAST TIME HE RECEIVED SHIPMENT THE SYRINGE THE NURSE USED TO DRAW UP MEDICATION FROM SINGLE DOSE VIAL WAS DEFECTIVE AND MEDICATION LEAKED OUT OF SYRINGE. DOSE WAS MISSED. NO ADVERSE EVENT REPORTED. PRODUCT NOT AVAILABLE FOR RETURN. LOT NUMBER AND EXPIRATION UNKNOWN. OUTCOME: RESHIP FOR MISSED DOSE SENT. NO ADDITIONAL INFORMATION PROVIDED. SYRINGE USED FOR RX ILARIS SDV 150MG/ML INJECT 150 MG UNDER THE SKIN EVERY MONTH. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360830 SYRINGE ++ 1ML L/L NO NEEDL BD SYRINGE, PISTON FMF BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1