BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSED WOUND SUCTION PVC DRAIN

    MDR report key: 1910952 · Received November 23, 2010

    Report

    Report Number
    1018233-2010-00140
    Event Type
    Injury
    Date Received
    November 23, 2010
    Report Date
    October 27, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GCY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. 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 THAT THE DRAIN BROKE OFF IN THE PT. PT WAS RETURNED TO SURGERY FOR REMOVAL OF DRAIN PORTION. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention