BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML L/L NO NEEDLE

    MDR report key: 8293698 · Received January 30, 2019

    Report

    Report Number
    MW5083577
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 21, 2019
    Report Date
    January 21, 2019
    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

    PATIENT SPONTANEOUSLY REPORTED THAT DURING HER CUVITRU DOSE OF 20GM ASSEMBLY 01/21, THE MEDICATION HAD LOADED INTO THE 60ML SYRINGE (CONTAINING CONTENTS OF 8GM AND 4GM DOSE VIALS) ¿BUSTED" AND THEN LEAKED WHEN SHE TRIED TO PUSH THE MEDICATION IN THE 50ML SYRINGE DURING PRIMING. PATIENT STATED THE MEDICATION LEAKED EVERYWHERE AND BECAUSE OF RISK OF CONTAMINATION. PT STATED SHE DID WANT TO USE THE LITTLE THAT IS LEFT FOR INFUSION. PT HAS MORE DOSES ON HAND AND NO MISSED DOSES HAPPENED. PER THE NOTES, THERE WERE NO MISSED DOSES. NOTHING HAS BEEN REPLACED YET. (B)(6) IS WORKING ON IT. REPORTED TO (B)(6) BY: PATIENTS/CAREGIVER. DOSE OR AMOUNT: 20GM, FREQUENCY: EVERY WEEK, ROUTE: SUBCUTANEOUSLY. DATES OF USE: FROM (B)(6) 2017 TO CURRENT. DIAGNOSIS OR REASON FOR USE: HYPOGAMMAGLOBULINEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83472 SYRINGE 60ML L/L NO NEEDLE PISTON, SYRINGE FMF BD

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR