BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD WOUND DRAIN

    MDR report key: 2163386 · Received July 6, 2011

    Report

    Report Number
    1018233-2011-00167
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 20, 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
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS DISCARDED BY THE USER FACILITY. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AS A FINISHED GOOD, QA PERFORMS RANDOM VISUAL INSPECTIONS FOR DAMAGED COMPONENTS PRIOR TO PRODUCT RELEASE. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING PRECAUTIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH THAT WHILE ATTEMPTING TO MANUALLY PULL THE DRAIN, THE END PIECE BECAME STUCK IN THE CLOSURE AND BROKE OFF IN THE PT. THE DRAIN WAS PLACED IN THE LUMBAR AREA ON (B)(6) 2011 FOR DRAINAGE AND REMOVED ON (B)(6) 2011. THE PT IS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention