BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD WOUND DRAIN

    MDR report key: 1621041 · Received March 1, 2010

    Report

    Report Number
    1018233-2010-00014
    Event Type
    Malfunction
    Date Received
    March 1, 2010
    Date of Event
    January 25, 2010
    Report Date
    March 1, 2010
    Manufacturer
    C. R. BARD, INC.
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE UNUSED SAMPLE IN ORIGINAL PACKAGING OPENED. UPON VISUAL INSPECTION IT WAS NOTED THAT THE DRAIN WAS BROKEN AT THE JUNCTION OF THE DRAIN WITH THE TROCAR. NO OTHER VISUAL DEFECTS WERE NOTED. THE BROKEN AREA SHOWED JAGGED EDGES AND STRESS MARKS WHICH IS INDICATIVE THAT EXCESSIVE FORCE WAS APPLIED CAUSING THE BREAKAGE. ON THE BROKEN PART THAT REMAINED ASSEMBLED TO THE TROCAR IT WAS OBSERVED THAT ENOUGH SOLVENT WAS APPLIED TO THE DRAIN, NO ASSEMBLY DISCREPANCIES WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE BREAKAGE. THE MANUFACTURING PROCESS WAS REVIEWED AND NO POTENTIAL CAUSE OF THE REPORTED ISSUE WAS FOUND. THE INTERNAL REJECTS HISTORY WAS REVIEWED FOR THIS PRODUCT AND NO DISCREPANCIES WERE FOUND RELATED TO THE REPORTED EVENT OF BREAKAGE DURING THE LAST 24 MONTHS. ALL VALUES WITHIN THE LAST TWO YEARS WERE ABOVE THOSE SPECIFIED IN THE INTERNATIONAL STANDARD FOR SURGICAL DRAINS ((B) (4)). THERE WERE NO MANUFACTURING DEFICIENCIES FOUND IN THE RETURNED SAMPLE THAT MAY HAVE CONTRIBUTED TO THE REPORTED PROBLEM. STANDARD LABELING OF INSTRUCTIONS FOR USE FOR CHANNEL DRAINS STATE THE FOLLOWING PRECAUTION: TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE, DRAINS SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRAIN TUBE WAS BROKEN NEAR THE CONNECTION OF TROCAR AND DRAIN TUBE. THE DRAIN WAS NOT USED AS IT WAS NOTED BEFORE USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD WOUND DRAIN GBX C. R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA