BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 321720 · Received March 15, 2001

    Report

    Report Number
    MW1021387
    Event Type
    Malfunction
    Date Received
    March 15, 2001
    Date of Event
    March 14, 2001
    Report Date
    March 15, 2001
    Manufacturer
    B-D
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IN PREPARATION OF CHEMO BY PHARMACIST IVP VENERISTINE WAS DRAWN INTO BD SAFETY-LOCK SYRINGE. WHEN ATTEMPTING TO REMOVE NEEDLE IN ORDER TO RE CAP THE SYRINGE, THE HUB SLIPS DOWN INTO A BARREL MAKING IT EXTREMELY DIFFICULT TO REMOVE NEEDLE AND INSERT SAFETY CAP. IN THE PROCESS CHEMO LEAKS BECAUSE HUB MUST BE REPOSITIONED WHILE TRYING TO MAINTAIN STERILITY AND ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11516 * B-D SAFETY-LOK 3ML SYRINGE FMF B-D * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other