BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT PUMP PACK

    MDR report key: 59846 · Received January 3, 1997

    Report

    Report Number
    1054408-1997-00001
    Event Type
    Malfunction
    Date Received
    January 3, 1997
    Manufacturer
    ALLEGIANCE - SURGICAL GROUP
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPONENT PART NUMBER: 7439. COMPONENT LOT NUMBER:083814. MANUFACTURER: JOHNSON AND JOHNSON MEDICAL. ON 12/11/96 JOHNSON AND JOHNSON WAS CONTACTED REQUESTING FULL INVESTIGATION AND REPORT OF EVALUATION. ON 1/23/97 JOHNSON AND JOHNSON RESPONDED BACK WITH RESULTS OF INVESTIGATION. IN RESPONSE TO PREVIOUS REPORTS OF MISCOUNTS CO HAS IMPLEMENTED A FOUR PHASE CORRECTIVE ACTION PLAN. ELECTRICAL MODIFICATIONS WERE MADE TO THE RAY-TEC EQUIPMENT TO REDUCE THE OCCURRENCE OF MISCOUNTS. AN EXTENDED EVALUATION OF MISCOUNT OCCURENCES FOLLOWING THE IMPLEMENTATION OF THE ELECTRICAL MODIFICATIONS HAS DETERMINED THE CORRECTIVE ACTION PLAN TO BE EFFECTIVE AND HAS SHOWN A DECREASE IN MISCOUNT COMPLAINTS. CO WILL CONTINUE TO MONITOR TRENDS.

    Description of Event or Problem · 1

    HOSP FOUND A PACK THAT HAD 8 EACH 4X8 GAUZE SPONGES INSIDE INSTEAD OF 10 EACH. THE HOSP IS CONCERNED THAT THEY GET A CONSISTENT AMOUNT OF SPONGES IN ORDER TO TRACK THE USAGE OF THIS PRODUCT IN THE PROCEDURE. THE HOSP CONTACT REPORTED THAT THE MISCOUNT OF SPONGES WAS NOT FOUND UNTIL AFTER THE PROCEDURE WAS COMPLETED, THEREFORE THE PT HAD TO BE OPENED BACK UP TO VERIFY THAT THE 2 SPONGES WERE NOT LEFT IN THE CHEST CAVITY. THERE WERE NO SPONGES FOUND. THE STAFF CONCLUDED THAT THERE MUST HAVE BEEN ONLY 8 SPONGES FROM THE BEGINNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT PUMP PACK ADULT PUMP PACK KKX ALLEGIANCE - SURGICAL GROUP SCV12ABFHC 259444

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN
    2 *