BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE COMFORT 1ML SYRINGE

    MDR report key: 19426446 · Received May 29, 2024

    Report

    Report Number
    MW5155549
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 27, 2024
    Report Date
    May 27, 2024
    Manufacturer
    ALLISON MEDICAL INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER USING ALLISONMEDICAL 1ML SURECOMFORT SYRINGES FROM A COMPOUNDING PHARMACY, ONE BROKE OFF (THE NEEDLE PART). ONE WAS CRACKED AND SPLIT WHEN DRAWN UP AND SPILLED THE EXPENSIVE MEDICATION. THIS BOTH OCCURRED SAME BATCH SAME DAY. I HAVE THE SYRINGES AND PICS. REF REPORT: MW5155548.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328727 SURE COMFORT 1ML SYRINGE SYRINGE, PISTON FMF ALLISON MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Other