BEUDAMED
    FDA Adverse Event Summary report: N

    INSULIN SYRINGE

    MDR report key: 32759 · Received May 8, 1996

    Report

    Report Number
    MW4001172
    Date Received
    May 8, 1996
    Report Date
    September 1, 1995
    Manufacturer
    RUGBY LABORATORIES
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REPORTS THAT SYRINGES WERE FOUND WITH NEEDLES UNCAPPED INSIDE NONSTERILE PACKAGES. ONE NEEDLE HAD A LARGE "BURR" AT THE TIP. SYRINGE BARRELS WERE SOMETIMES NOT STRAIGHT. PLUNGER TIPS SOMETIMES DID NOT SEAL AGAINST INNER SURFACE OF BARREL SO THAT AIR LEAKED IN OR INSULIN LEAKED OUT. OCCURRED PRIOR TO DISCOVERING PROBLEM. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSULIN SYRINGE SYRINGE, 1CC, U-100 28G, 1/2" NEEDLE FMF RUGBY LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO