BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAT SEAL STERILIZATION POUCH

    MDR report key: 2559772 · Received April 30, 2012

    Report

    Report Number
    2559772
    Event Type
    Malfunction
    Date Received
    April 30, 2012
    Date of Event
    April 6, 2012
    Report Date
    April 30, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOR THE PAST MONTH THE DEPARTMENT HAS BEEN HAVING DIFFICULTY WITH THE POUCH TEAR ON THE HEAT SEAL STERILIZATION POUCH. IT RIPS RATHER THAN TEARS. THEY ARE ALL FROM THE SAME LOT. TRYING TO DETERMINE IF THERE IS A PROBLEM WITH THE PRODUCT OR STAFF HANDLING. THE RIPPING INSTEAD OF PEELING CONTAMINATES THE INSTRUMENT SO IT IS UNABLE TO BE USED AND MUST BE REPROCESSED.======================MANUFACTURER RESPONSE FOR HEAT SEAL STERILIZATION POUCH, HEAT SEAL STERILIZATION POUCH (PER SITE REPORTER).======================STATED THEY HAVE HAD NO OTHER COMPLIANTS. SUGGESTED THEY COME IN TO RETRAIN STAFF ON OPENING OF PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEAT SEAL STERILIZATION POUCH HEAT SEAL STERILIZATION POUCH KCT CARDINAL HEALTH * 101009A-SH

    Patients

    Seq Age Sex Outcome Treatment
    1 *