BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD CWS 400 CLOSED WOUND SUCTION KIT

    MDR report key: 1140934 · Received August 28, 2008

    Report

    Report Number
    1018233-2008-00062
    Event Type
    Injury
    Date Received
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GCY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFO WAS PROVIDED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT AS A SUBASSEMBLY, Q.A. PERFORMED A VISUAL INSPECTION TO VERIFY THAT THERE WERE NO CUTS OR TEARS ON THE SURFACE OF THE TUBE AND PERFORMED A BREAK STRENGTH TEST. AS A FINISHED GOOD, QA PERFORMED A VISUAL INSPECTION FOR DAMAGED COMPONENTS. NO POTENTIAL CAUSE OF THE REPORTED ISSUE WAS FOUND DURING THE MANUFACTURING PROCESS REVIEW OF THE DHR. AN INTERNAL REJECTS RECORDS REVIEW WAS PERFORMED AND DID NOT SHOW ANY REJECTS RELATED TO TENSILE VALUES. ALL VALUES WITHIN THE LAST TWO YEARS WERE ABOVE THOSE SPECIFIED IN THE INTERNATIONAL STANDARD FOR SURGICAL DRAINS. THERE WAS NO EVIDENCE OF ANY MANUFACTURING ISSUES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING PRECAUTIONS TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE DRAIN. AVOID SUTURING THOROUGH DRAINS. DRAIN SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAINS SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. 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. SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WOUND DRAIN BROKE OFF INSIDE THE PT ONE DAY POST-OP DURING REMOVAL. ACCORDING TO THE DR, THERE WERE NO PRE-EXISTING PATIENT CONDITIONS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO PERFORATIONS MADE IN THE DRAIN OR SUTURES PLACED IN THE DRAIN AND X-RAYS WERE MADE TO VERIFY PLACEMENT. THERE WAS NO PINCHING OR BINDING OF THE DRAIN NOTED AFTER PLACEMENT OR DURING REMOVAL, AND NO RESISTANCE WAS ENCOUNTERED DURING REMOVAL. THE PT WAS RETURNED TO SURGERY TO HAVE THE THREE INCH RETAINED DRAIN SECTION REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD CWS 400 CLOSED WOUND SUCTION KIT GCY C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention