BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBERCULIN SYRINGE

    MDR report key: 450092 · Received February 26, 2003

    Report

    Report Number
    MW4003479
    Event Type
    Malfunction
    Date Received
    February 26, 2003
    Report Date
    February 26, 2003
    Manufacturer
    BD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM THE HOSPITAL 5/12/2003: HERE IS THE RESPONSE THAT THEY RECEIVED FROM THE BD REP. THE WAY REPORTER READS IT, THEY SAY THEY ARE CHANGING THEIR INSULIN SYRINGES BUT, THEY CHANGED THE 25G, WHICH IS THE TB SYRINGE. UNLESS, THEY INTEND ON CHANGING THE INSULIN SYRINGE AS WELL. IF THAT IS THEIR INTENT, THEY SHOULD HAVE DONE BOTH CHANGES AT THE SAME TIME.

    Description of Event or Problem · 1

    B-D HAS APPARENTLY RECENTLY CHANGED THE COLOR OF THEIR PACKAGING FOR TUBERCULIN SYRINGES TO ORANGE. THIS IS THE SAME COLOR AS THEIR INSULIN SYRINGE PACKAGES. GIVEN THE RECENT ALERTS REGARDING INSULIN ERRORS, THIS NEEDS TO BE TAKEN CARE OF QUICKLY. CO IS TALKING TO STAFF AND WARNING THEM OF THE POTENTIAL PROBLEM, AND FOR RIGHT NOW TRYING TO KEEP THE SYRINGES SEPARATED. CO'S CSR DEPT IS COMMUNICATING WITH THE B-D REP, BUT NOT SURE WHAT ARRANGEMENTS HAVE BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD TUBERCULIN SYRINGE TUBERCULIN SYRINGE FMF BD * *
    2 B-D INSULIN SYRINGE INSULIN SYRINGE FMF BD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *