BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSED WOUND SUCTION KIT

    MDR report key: 2092871 · Received May 11, 2011

    Report

    Report Number
    1018233-2011-00094
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 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
    SD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR EVALUATION FINDING THE DRAIN BROKEN OFF AT ONE OF THE EYES. 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 REVIEW OF THE MANUFACTURING PROCESS SHOWED THAT THE DRAIN IS REC'D FROM AN EXTERNAL SUPPLIER WHO CERTIFIES THAT THE PRODUCT HAS BEEN MANUFACTURED ACCORDING TO THE REQUIREMENTS ESTABLISHED BY THE MANUFACTURER. 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 A DRAIN WAS PLACED IN A (B)(6) YEAR OLD FEMALE WHO HAD UNDERGONE A TOTAL HIP REPLACEMENT ON (B)(6) 2011. ON (B)(6) 2011, WHILE THE DRAIN WAS BEING REMOVED, IT BROKE AND A PIECE WAS RETAINED. THE PT RETURNED TO SURGERY ON (B)(6) 2011 FOR RIGHT HIP IRRIGATION AND DRAINAGE AND SUBSEQUENTLY ENDED UP IN THE ICU. THE PT HAD A PROLONGED LENGTH OF STAY OF 10 DAYS.

    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 63 YR Hospitalization| R