BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEAMPLUS INTEGRATOR

    MDR report key: 1655916 · Received March 29, 2010

    Report

    Report Number
    1655916
    Event Type
    Malfunction
    Date Received
    March 29, 2010
    Date of Event
    March 26, 2010
    Report Date
    March 29, 2010
    Manufacturer
    SPS MEDICAL SUPPLY CORP.
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    OVER TWO DAYS, A TOTAL OF THREE (3) STERILIZATION INTEGRATORS LEAKED ONTO INSTRUMENTS BEING STERILIZED. TWO (2) INTEGRATORS WERE FROM LOT # 254. THE THIRD WAS FROM LOT # 253.MANUFACTURER WAS CONTACTED AND DEFECTIVE PRODUCT IS BEING RETURNED TO MANUFACTURER TODAY. LEAK REQUIRED CLEANING OF INSTRUMENTS AND REPEATING STERILIZATION.MANAGER ALSO NOTED THAT THERE HAD BEEN ONE OTHER INTEGRATOR WHICH LEAKED ON TWO MONTHS PREVIOUS; THAT WAS FROM LOT # 248.WE WERE UNABLE TO EXPLAIN THE LEAKS BASED UPON HANDLING OF DEVICES HERE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================FLAW IN MANUFACTURING PROCESS RESULTING IN INTEGRATOR LEAKING ON INSTRUMENTS====================== MANUFACTURER RESPONSE FOR STERILIZATION INTEGRATOR, SPS INTEGRATOR======================MANUFACTURER REQUESTED RETURN OF THE FAILED PRODUCTS AND SAMPLES OF SAME LOT # FROM OUT SHELVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEAMPLUS INTEGRATOR STERILIZATION INTEGRATOR JOJ SPS MEDICAL SUPPLY CORP. * 254

    Patients

    Seq Age Sex Outcome Treatment
    1 *