BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSED WOUND SUCTION KIT

    MDR report key: 2030703 · Received March 18, 2011

    Report

    Report Number
    1018233-2011-00043
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    December 8, 2010
    Report Date
    February 17, 2011
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETAINED BY THE PT'S FAMILY. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING PRECAUTIONS "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 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." AN ADDITIONAL WARNING STATES: " DRAIN BREAKAGE MAY REQUIRE SURGICAL REMOVAL." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD A DRAIN PLACED AFTER A KNEE REPLACEMENT SURGERY. UPON MANUAL REMOVAL, THE DRAIN BROKE. THE DRAIN WAS INDWELLING FOR ONE DAY. THE PT RETURNED TO SURGERY ON (B)(6) 2011 FOR REMOVAL OF THE RETAINED DRAIN PORTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention