BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLADEX SAFESYSTEM

    MDR report key: 1770086 · Received July 12, 2010

    Report

    Report Number
    1770086
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 12, 2010
    Manufacturer
    ASTRAZENECA
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    ZOLADEX (GOSERELIN ACETATE) IMPLANT IS PROVIDED AS A READY-MIXED, READY-TO-USE STERILE SYRINGE SYSTEM WITH A PROTECTIVE SLEEVE DESIGNED TO REDUCE THE RISK OF NEEDLE STICK INJURIES. IN ORDER TO DEPLOY THE SLEEVE ONE MUST DEPRESS THE PLUNGER COMPLETELY, AT WHICH POINT THE SLEEVE SHOULD SLIDE TO COVER THE NEEDLE. WE HAVE RECEIVED TWO REPORTS REGARDING THE FAILURE OF THE SLEEVE TO ACTIVATE DESPITE THE PLUNGER HAVING BEEN FULLY DEPRESSED, THEREBY PLACING THE NURSES AT RISK FOR NEEDLE STICKS.THERE HAVE BEEN AT LEAST 9 INSTANCES OF THE SLEEVE NOT ENGAGING IN 2 LOTS: GC 277 AND GC781.====================== HEALTH PROFESSIONAL'S IMPRESSION======================FULL DEPRESSION OF THE PLUNGER DID NOT CAUSE THE PROTECTIVE SLEEVE TO ACTIVATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLADEX SAFESYSTEM SYRINGE WITH PROTECTIVE CAP MEG ASTRAZENECA NONE GC781 ON THE SYRINGE

    Patients

    Seq Age Sex Outcome Treatment
    1 *