BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT SYRINGE

    MDR report key: 14677222 · Received June 10, 2022

    Report

    Report Number
    MW5110284
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    June 8, 2022
    Report Date
    June 9, 2022
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONE OF THE PHARMACY TECHNICIANS OPENED TWO SEPARATE INDIVIDUAL MONOJECT 3ML SYRINGES WITH NEEDLES (REF 1180320112; LOT #203850). ON ONE, THE NEEDLE WAS COATED IN GRAY CONTAMINATION (MOLD VS DUST VS ?). IT IS ALSO WITHIN THE NEEDLE HUB. ON THE SECOND SYRINGE, THE GRAY CONTAMINATE WAS WITHIN THE BARREL AND SYRINGE HUB. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813321 MONOJECT SYRINGE SYRINGE, PISTON FMF COVIDIEN REF 1180320112 203850
    2814399 MONOJECT SYRINGE SYRINGE, PISTON FMF COVIDIEN REF 1180320112 203850

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown