BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY GLIDE

    MDR report key: 450087 · Received March 3, 2003

    Report

    Report Number
    MW4003478
    Event Type
    Malfunction
    Date Received
    March 3, 2003
    Report Date
    March 3, 2003
    Manufacturer
    BD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECENTLY, THEY RECEIVED NEW 1CC SYRINGES IN THE HOSPITAL SUPPLY CHAIN THAT HAD ORANGE LABELING ON THE PACKAGE (FROM BD). THESE SYRINGE PACKAGES LOOK EXACTLY LIKE INSULIN SYRINGES AND THEY FEEL THIS IS LIKELY TO LEAD TO AN ERROR IN INSULIN ADMINISTRATION. THEY LATER DISCOVERED FROM BD, CO'S VENDOR VIA CO'S PURCHASING ARRANGEMENT, THAT THE ORANGE LABELING WAS MANDATED BY THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO). THEY SELECTED ORANGE LABELING FOR ALL SYRINGES WITH 25 GAUGE NEEDLES. THE CO'S SUPPLIER WAS ONE OF THE LAST COMPANIES TO CHANGE THE PACKAGING, PER THEIR REPORT. CO IS NOW CHANGING TO 26 GAUGE NEEDLES ON 1CC SYRINGES SO THEY DON'T HAVE ANY ORANGE PACKAGED SYRINGES IN THE CLINICAL AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY GLIDE 1CC SYRINGE FMF BD 25G X 5/8" *
    2 INSULIN SYRINGE INSULIN SYRINGE FMF BD 100 UNIT SYRINGE *

    Patients

    Seq Age Sex Outcome Treatment
    1 *