BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN - FILTER FLOW IV

    MDR report key: 533494 · Received June 18, 2004

    Report

    Report Number
    MW1032429
    Event Type
    Malfunction
    Date Received
    June 18, 2004
    Date of Event
    June 14, 2004
    Report Date
    June 16, 2004
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/23/04: THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS RETURNED TO B. BRAUN FOR EVALUATION. THE SET WAS TESTED TO THE APPROPRIATE SPECIFICATION AND FOUND TO BE LEAKING AT THE SOLVENT BONDED JOINT BETWEEN THE IV TUBING AND THE TUBING COUPLER. A REVIEW OF THE BATCH RECORD INDICATED THAT THIS LOT OF PRODUCT MET THE REQUIRED SPECIFICATIONS. A HISTORICAL REVIEW OF THE PRODUCT INCIDENT REPORTS, DATING BACK TO 2000, REVEALED NO OTHER REPORTED INCIDENTS OF THIS NATURE AGAINST THIS SET, HOWEVER, THERE HAVE BEEN OTHER INCIDENTS OF LEAKAGE AT SOLVENT BONDED JOINT AGAINST OTHER SIMILAR SETS. THE REPORTED INCIDENT RATE IS VERY LOW COMPARED TO THE NUMBER OF SETS RELEASED TO THE FIELD. IN CO'S EFFORTS TOWARD CONTINUOUS PRODUCT IMPROVEMENTS, CO HAS INITIATED A CORRECTIVE ACTION / PREVENTIVE ACTION REQUEST (CAR #2004-03-001) TO ADDRESS THE ISSUE OF LEAKAGE AT SOLVENT BONDED JOINTS. THE CAPA PROCESS WILL ENSURE ROOT CAUSE IDENTIFICATION, APPROPRIATE CORRECTIVE ACTION AND FOLLOW-UP TO CONFIRM CORRECTIVE ACTION EFFECTIVENESS. ADDITIONAL CONTROLS HAVE ALREADY BEEN IMPLEMENTED TO THE SOLVENT BONDING PROCESS INCLUDING CHANGING OF THE SOLVENT EVERY FOUR HOURS AND UTILIZING DIFFERENT SOLVENT DISPENSERS WHICH PROVIDE BETTER SOLVENT APPLICATION.

    Description of Event or Problem · 1

    FILTER FLOW IN ADMINSTRATION SET LEAKS AT GREEN RUBBER CONNECTION ON TUBINGS, TUBING LOT #060507910. LEAKED WITH 1ST TIME USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN - FILTER FLOW IV ADMINISTRATION SET FPA B. BRAUN MEDICAL, INC. REF 352426 V1712F 060507910

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR 2004, 6:30P