BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD WOUND DRAIN

    MDR report key: 1192444 · Received October 7, 2008

    Report

    Report Number
    1018233-2008-00071
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    August 18, 2008
    Report Date
    October 7, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFO WERE PROVIDED FOR EVAL. THE COMPONENT USED IN THE MFR OF THE REPORTED PROD CATALOG NUMBER IS REC'D FROM AN EXTERNAL SUPPLIER. INCOMING QA PERFORMS VISUAL INSPECTION TO VERIFY THAT DRAIN ASSEMBLIES ARE FREE OF AIR, BUBBLES, NICKS, CUTS, POCK MARKS AND SHORT SHOTS, PERFORM DIMENSIONAL INSPECTION, AND AN INSTRON BREAK STRENGTH TEST. ALSO, SUPPLIER CERTIFIES THAT PROD HAS BEEN MFG ACCORDING TO SPECS VIA A CERTIFICATE OF COMPLIANCE. AS A FINISHED GOOD, QA PERFORMS VISUAL INSPECTION TO VERIFY THAT PROD IS FREE OF CUTS OR TEARS ON THE SURFACE OF THE DRAIN. THE INCOMING QUAL ASSURANCE RECORDS FOR THE DRAIN USED IN THE MFR OF THE REPORTED PROD CATALOG NUMBER, WERE REVIEWED AND THE RECORDS DID NOT SHOW ANY REJECTS RELATED TO TENSILE VALUES. ALL VALUES WITHIN THE LAST TWO YRS WERE ABOVE THOSE SPECIFIED IN THE INTL STANDARD FOR SURGICAL DRAINS. THERE WAS NO EVIDENCE OF ANY MFG ISSUES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. STANDARD LABELING OF INSTRUCTIONS FOR USE FOR CHANNEL WOUND DRAINS SHOWS: TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: AVOID SUTURING THROUGH DRAINS. DRAINS 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. BASE LINE REPORT PREVIOUSLY FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WOUND DRAIN THAT WAS PLACED FOR ABDOMINAL CAVITY DRAINAGE, BROKE UPON REMOVAL. THE EVENT OCCURRED FOUR DAYS AFTER SURGERY. RESISTANCE WAS REPORTEDLY ENCOUNTERED AT DRAIN REMOVAL AND THE DRAIN WAS BROKEN. THE BROKEN PORTION WAS NOT INSIDE THE ABDOMINAL CAVITY. THE DRAIN PORTION WAS REMOVED AT THE TIME OF BREAKAGE BY MAKING AN INCISION INTO THE SKIN. NO FURTHER COMPLICATIONS WERE REPORTED.

    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 UNK Required Intervention