BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT SYRINGE CAPS

    MDR report key: 11854866 · Received May 19, 2021

    Report

    Report Number
    MW5101439
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    May 17, 2021
    Report Date
    May 17, 2021
    Manufacturer
    COVIDIEN
    Product Code
    KDC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    MONOJECT SYRINGE CAPS REF 8881682119, LOT NUMBER: 2101217164 -- SYRINGE CAPS ARE NOT STAYING ON THE 10ML SYRINGE. WE USE THIS PROCESS ALL THE TIME AND SOMETHING IS WRONG WITH THESE CAPS. WE HAD TO USE AN ALTERNATE SYRINGE CAP TO PREVENT THE CAPS FROM FALLING OFF AND RISK POTENTIAL CONTAMINATION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742856 MONOJECT SYRINGE CAPS MONOJECT 12ML SYRINGE KDC COVIDIEN 2101217164
    742857 INSTRUMENT, SURGICAL, DISPOSABLE SYRINGE, PISTON FMF COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other