BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60ML LUER LOCK SYRINGE DISPOSABLE WITHOUT NEEDLE

    MDR report key: 15720410 · Received November 2, 2022

    Report

    Report Number
    MW5113056
    Event Type
    Malfunction
    Date Received
    November 2, 2022
    Date of Event
    November 1, 2022
    Report Date
    November 1, 2022
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MEDLINE 60ML SYRINGE THAT IS INDIVIDUAL WRAPPED WAS FOUND TO HAVE A LONG HAIR COMING OUT OF THE PLUNGER AFTER DRAWING UP MEDICATION IN STERILE ENVIRONMENT. REF SYR160010, LOT 220101, EXP 12-1-2026. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498366 60ML LUER LOCK SYRINGE DISPOSABLE WITHOUT NEEDLE SYRINGE, PISTON FMF MEDLINE INDUSTRIES, LP - NORTHFIELD SYR160010 220101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown