BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY FIRST LUER LOCK 1 ML 23 GAUGE/1 INCH SYRINGE

    MDR report key: 11663735 · Received April 13, 2021

    Report

    Report Number
    MW5100743
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    April 11, 2021
    Report Date
    April 12, 2021
    Manufacturer
    ALLISON MEDICAL, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    [CAREPOINT SAFETY FIRST LUER LOCK 1 ML 23 GAUGE/1 INCH SYRINGE, REF 35-8204] TREATMENT UNDER EMERGENCY USE AUTHORIZATION(EUA): SYRINGE WAS BEING USED TO DELIVER JANSSEN COVID 19 VACCINE AND WAS PROVIDED IN OUR ANCILLARY KITS FOR USE; 2 TIMES THE NEEDLE FELL OFF THE SYRINGE DURING VACCINE ADMINISTRATION DESPITE TIGHTENING THE LEUR LOCK CONNECTION PRIOR TO USE; 1 TIME THE SYRINGE STOPPER WAS SLANTED AND WOULDN'T ALLOW A FULL DOSE TO BE ADMINISTERED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554982 SAFETY FIRST LUER LOCK 1 ML 23 GAUGE/1 INCH SYRINGE SYRINGE, PISTON FMF ALLISON MEDICAL, INC.
    554983 SAFETY FIRST LUER LOCK 1 ML 23 GAUGE/1 INCH SYRINGE SYRINGE, PISTON FMF ALLISON MEDICAL, INC.
    554984 SAFETY FIRST LUER LOCK 1 ML 23 GAUGE/1 INCH SYRINGE SYRINGE, PISTON FMF ALLISON MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1