BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B-D (BECTON - DICKINSON)

    MDR report key: 481593 · Received August 22, 2003

    Report

    Report Number
    MW1029397
    Event Type
    Malfunction
    Date Received
    August 22, 2003
    Date of Event
    August 1, 2003
    Report Date
    August 17, 2003
    Manufacturer
    B-D
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    FACILITY ORDERED STERILE 30ML SYRINGES FROM B-D. HOWEVER, WHEN FACILITY OPENED THE STERILE PACKAGE, THERE WAS DIRT/GRIT ON THE INSIDE. FACILITY CONTACTED THE B-D SUPPLIER ABOUT THE PROBLEM. SOMEONE, A B-D REPRESENTATIVE, WAS SUPPOSED TO PICK UP THE CONTAMINATED SYRINGES, BUT NEVER ARRIVED. APPROXIMATELY TWO WEEKS LATER FACILITY WAS MAILED A LETTER FROM B-D QUALITY MANAGEMENT, STATING THAT THEY WERE INVESTIGATING THE PROBLEM AND WOULD CONTACT THE FACILITY UPON COMPLETION OF THEIR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B-D (BECTON - DICKINSON) 30ML SYRINGE FMF B-D 309650 2275147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other