BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMOSTOP

    MDR report key: 500603 · Received November 21, 2003

    Report

    Report Number
    MW1030339
    Event Type
    Malfunction
    Date Received
    November 21, 2003
    Date of Event
    November 12, 2003
    Report Date
    November 21, 2003
    Manufacturer
    RADI MEDICAL SYSTEMS, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OPENED PACKAGE TO USE AND FOUND CONTAMINATED PRODUCT IN ITS ORIGINAL PACKAGING.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 1/15/04: NO COMPLAINT REPORT WAS SENT FROM THE CUSTOMER DIRECTLY TO RADI MEDICAL SYSTEMS. THE REPORTING HOSPITAL HAS INFORMED RADI MEDICAL SYSTEMS THAT THEY USE REPROCESSED UNITS OF FEMOSTOP FEMORAL COMPRESSION SYSTEM. THE REPROCESSING FACILITY USED BY THE HOSPITAL IS STERILMED, INC., HOLDING A 510(K), (K012574) FOR REPROCESSING FEMOSTOP FEMORAL COMPRESSION SYSTEM. THE EVENT THAT INITIATED THE VOLUNTARY FDA MEDWATCH REPORT WAS DESCRIBED AS FOLLOWS: "OPENED PACKAGE TO USE AND FOUND CONTAMINATED PRODUCT IN ITS ORIGINAL PACKAGING". SOON AFTER THE VOLUNTARY REPORT WAS SENT OFF, THE HOSPITAL PERSONNEL REALIZED THAT THERE HAD BEEN A MIX-UP OF UNITS TO BE REPROCESSED AND NON-REPROCESSED UNITS OF FEMOSTOP FEMORAL COMPRESSION SYSTEM INTENDED FOR PT USE. THE DEFECTIVE DEVICE SUBJECT TO THE VOLUNTARY REPORT WAS A "USED" UNIT THAT SHOULD HAVE PLACED IN A SEPARATE LOCATION TO BE RETURNED TO STERILMED INC FOR REPROCESSING AND NOT BACK ON THE SHELF AS STERILE INVENTORY. BASED ON THE COMMENTS IN THE VOLUNTARY MDR AND OBSERVATIONS BY RADI PERSONNEL, IT APPEARS THAT THE HOSPITAL PRACTICE IS TO RETURN USED UNITS INSIDE OF THE ORIGINAL PACKAGING FROM RADI MEDICAL SYSTEM. ALSO, MFR BELIEVES THAT THE UNIT WAS NOT LABELLED IN ACCORDANCE WITH FDA GUIDANCE REQUIRING THE STATEMENT "CAUTION: FOR MANUFACTURING, PROCESSING, OR REPACKING" TO BE PLACED ON UNITS INTENDED FOR REPROCESSING, "LABELLING RECOMMENDATIONS FOR SINGLE-USE DEVICES REPROCESSED BY THIRD PARTIES AND HOSPITALS; FINAL GUIDANCE FOR INDUSTRY AND FDA" (JULY 30, 2001) AT 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMOSTOP FEMORAL SHEATH COMPRESSION DEVICE MGB RADI MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other