BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMOSTOP

    MDR report key: 480786 · Received August 20, 2003

    Report

    Report Number
    MW1029370
    Event Type
    Injury
    Date Received
    August 20, 2003
    Date of Event
    July 22, 2003
    Report Date
    August 20, 2003
    Manufacturer
    RADI MEDICAL SYSTEMS
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/12/03: NO COMPLAINT REPORT WAS SENT FROM THE CUSTOMER DIRECTLY TO RADI MEDICAL SYSTEMS. LETTER TO RADI MEDICAL SYSTEMS IN READINGS ON DECEMBER 1ST 2003, WAS CO'S FIRST NOTICE OF THE EVENT. THAT LETTER HAS BEEN FOWARDED TO THE CORPORATE QUALITY AND REGULATORY DEPT. THE REPORTING HOSP WAS CONTACTED. THE DEVICE COULD NOT BE RETRIEVED AND WAS MOSTLY LIKELY DISPOSED OF. THE REPORTED PROBLEM APPEARS TO BE A CRACK IN THE POLYCARBONATE LUER CONNECTOR. THERE HAVE BEEN NO CHANGES IN THE DESIGN, MATERIAL OR STERILIZATION PROCESS OF FEMOSTOP FEMORAL COMPRESSION SYSTEM AS SINGLE-USE DEVICE RELATED TO THE EVENT. THE REPORTING HOSP HAS INFORMED THAT REPROCESSED UNITS OF FEMOSTOP FEMORAL COMPRESSION SYSTEM ARE USED. THE REPROCESSING FACILITY USED BY THE HOSPITAL IS STERILMED, INC., HOLDING A 510(K), K012574 FOR REPROCESSING CO'S FEMOSTOP FEMORAL COMPRESSION SYSTEM. THEREFORE, CO HAS REASON TO BELIEVE THAT THE DEFECT DEVICE MAY HAVE BEEN REPROCESSED. SOME CLEANING LIQUIDS ARE KNOWN TO RELEASE MOULDING TENSIONS IN THE POLYCARBONATE INDUCING A POTENTIAL FOR CRACKING. THE FAILURE RATE, I.E. FOR LUER CONNECTOR CRACKS, IS ZERO BASED ON REVIEW OF CO'S COMPLAINT FILES SINCE YEAR 2000. THE SHELFLIFE OF FEMOSTOP FEMORAL COMPRESSION SYSTEM IS 2 YEARS. WHETHER THE REPROCESSOR LABELS THE REPROCESSED DEVICE BEYOND THE ORIGINAL 2 YEARS, CO DOES NOT KNOW. IT MUST BE "IMPOSSIBLE" FOR THE PROCESSOR TO KNOW THE REMAINING SHELF LIFE OF THE SUD WHEN RECEIVED FOR REPROCESSING FOR THE FIRST TIME. CO IS NOT AWARE OF WHICH VERSION OF FEMOSTOP FEMORAL COMPRESSION SYSTEM WAS INVOLVED IN THE INCIDENT. RADI MEDICAL SYSTEMS HAS A SALES ORGANIZATION OF ITS OWN SINCE JULY 1ST, 2002. THEIR PREVIOUS DISTRIBUTOR WAS CR BARD, INC.

    Description of Event or Problem · 1

    BEGAN PUMP UP BULB AND NOTICED PRESSURE LOSS PRIOR TO GAUGE INDICATING PRESSURE LOSS. THEN NOTED CRACK AT SCREW CONNECTION. RADI REP NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMOSTOP ARTERIAL PRESSURE DEVICE DXC RADI MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention