BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK

    MDR report key: 3151349 · Received May 22, 2013

    Report

    Report Number
    3151349
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    March 11, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    FGY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    NEUPOGEN WAS USED AND PUT BACK IN THE REFRIGERATOR ON PCU (PATIENT CARE UNIT). A NEEDLELESS BLUNT WAS USED TO DRAW IT UP AND THE STOPPER WENT INSIDE THE VIAL. NO HARM TO STAFF OR THE PATIENT.THE BD REP CAME TO MATERIALS MANAGEMENT - GAVE HIM THE BLUNT (IN PACKAGE). THE CANCER CENTER SENT OVER WITH THEIR PRODUCT FAILURE REPORTS. ALSO SHOWED HIM THE NEUPOGEN VIAL THAT WAS SENT TO MATERIALS MANAGEMENT. HE MAINLY TOOK DOWN INFORMATION, AND IS LOOKING FOR MORE DEFECTIVE SAMPLES AND LOT INFORMATION AS WE HAVE IT.THE REP SAID THAT HE HAS NOT HEARD OF ANY ISSUES LIKE THIS GOING ON ANYWHERE ELSE, AND MENTIONED THE RUBBER STOPPERS AT TIMES CAN HAVE ISSUES, BUT HE CERTAINLY TOOK OUR COMPLAINT SERIOUSLY AND IS GOING TO DO EVERYTHING HE CAN TO RESEARCH IT. MATERIALS MANAGEMENT WILL CONTINUE TO MONITOR AND ACCEPT ANY OTHER PRODUCT FAILURES, HOPEFULLY WITH SAMPLES AND PACKING OF THE DEFECTIVE BLUNTS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?DRAWING UP MEDICINE FOR PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226190 INTERLINK CANNULA, INJECTION FGY BECTON, DICKINSON & CO. DG536001 (01) 00382903034031

    Patients

    Seq Age Sex Outcome Treatment
    1 *