BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSED WOUND SUCTION EVACUATOR KIT

    MDR report key: 2160798 · Received July 7, 2011

    Report

    Report Number
    1018233-2011-00168
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 15, 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
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL DRAIN SAMPLE MEASURING 3 1/8 INCHES IN LENGTH WAS RETURNED TO BARD FOR EVALUATION. UPON VISUAL INSPECTION, THERE WAS A CLEAN CUT ON ONE END OF THE DRAIN PIECE. THE OTHER END OF THE DRAIN SAMPLE WAS BROKEN AT ONE OF THE DRAINAGE EYES. NO FURTHER TESTING OF THE SAMPLE COULD BE PERFORMED DUE TO THE CONDITION OF THE SAMPLE. 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 "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 THAT WAS PLACED IN A (B)(6) YEAR OLD FEMALE PATIENT DURING A LEFT KNEE ARTHROPLASTY, BROKE DURING REMOVAL. THE DRAIN WAS PLACED ON (B)(4) 2011 AND WAS REMOVED ON (B)(4) 2011. THE PHYSICIAN MET RESISTANCE WHEN TRYING TO REMOVE IT AND NOTICED THAT AFTER REMOVAL, THE TIP WAS BROKEN OFF. PATIENT WAS TAKEN TO SURGERY TO REMOVE BROKEN DRAIN ON (B)(4) 2011. THERE WERE NO SUTURES FOUND IN THE DRAIN WHEN REMOVED. THE PATIENT IS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention