BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD CLOSED WOUND EVACUATOR

    MDR report key: 1930272 · Received September 23, 2010

    Report

    Report Number
    1018233-2010-00099
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    April 30, 2010
    Report Date
    August 24, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GCY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION. WITHOUT A LOT NUMBER, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, REVIEW OF THE MFG PROCESS DID NOT FIND ANY RELATED ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING PRECAUTIONS TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: "ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE DRAIN. AVOID SUTURING THROUGH DRAIN. 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. DRAIN SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAIN 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." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A MAUDE ADVERSE EVENT REPORT THAT A PT HAD A HEMOVAC DRAIN PLACED AFTER A RIGHT TOTAL KNEE ARTHROPLASTY SURGERY. THE DRAIN WAS REMOVED AND THE PT WAS SENT FOR THERAPY AND RECOVERY. IT WAS CONFIRMED DURING A POST-OP SURGICAL VISIT X-RAY THAT THERE WAS A FOREIGN OBJECT IN THE RIGHT KNEE. THE FOREIGN OBJECT WAS REMOVED FROM THE RIGHT KNEE VIA ARTHROSCOPY. NO ADDITIONAL INFO COULD BE OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention