BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOUND DRAIN

    MDR report key: 1895505 · Received November 10, 2010

    Report

    Report Number
    1423537-2010-00057
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 11, 2010
    Report Date
    November 10, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, THE ACTUAL PRODUCT INVOLVED IN THIS INCIDENT WAS NOT RETURNED FOR OUR INVESTIGATION. WITH THE INFORMATION PROVIDED A COMPLETE INVESTIGATION CANNOT BE PERFORMED AND THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. WITHOUT THE CUSTOMER SAMPLE, NOR LOT NUMBER WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT. WOUND DRAINS WILL PERFORM AS INTENDED AS LONG AS THEY ARE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). "DRAINS OR TUBING SHOULD NOT BE HANDLED WITH ANY INSTRUMENTS. THIS CAN LEAD TO TEARING, WARPING, OR WEAKENING AND SUBSEQUENT BREAKAGE OF THE DRAIN. TO FACILITATE REMOVAL OF THE DRAIN, THE DRAIN AND TUBING PORTIONS SHOULD NOT BE CURLED, PINCHED, OVER-STRETCHED OR SUTURED; EITHER INTERNALLY OR EXTERNALLY. DO NOT SUTURE THE DRAIN(S). DRAINS SHOULD BE PLACED AND REMOVED CAREFULLY BY HAND ONLY WITH A SLOW, STEADY PRESSURE. EXCESSIVE FORCE MAY RESULT IN BREAKAGE. DURING PLACEMENT AND REMOVAL OF THE DRAIN, DO NOT NICK, CUT, TEAR OR OTHERWISE DAMAGE THE DRAIN AS THIS MAY LEAD TO BREAKAGE. LEAVING THE DRAIN IMPLANTED FOR ANY PERIOD OF TIME WHICH ALLOWS FOR TISSUE INGROWTH AROUND THE DRAIN AND INTO THE HOLES, MAY CAUSE BREAKAGE ON REMOVAL." WE WILL CONTINUE TO MONITOR TRENDS AND UTILIZE THE INFORMATION AS PART OF CONTINUOUS IMPROVEMENT.

    Description of Event or Problem · 1

    (B)(4). RN ATTEMPTED TO REMOVE THE #10 JACKSON-PRATT DRAIN PER MD ORDERS. THE RN POSITIONED THE PATIENT, EXPLAINED THE PROCEDURE, DEFLATED THE BULB AND REMOVED THE STITCHES FROM INSERTION SITE. RN FELT RESISTANCE AS SHE PULLED ON THE TUBING WHICH CAME OUT UP TO THE DISTAL END AND THEN SNAPPED AT THE CONNECTION BETWEEN THE CATHETER AND THE WHITE END OF THE CATHETER. THE PATIENT WAS TAKEN BACK TO SURGERY FOR RETRIEVAL OF THE DISTAL RETAINED PORTION OF THE JACKSON-PRATT CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOUND DRAIN WOUND DRAIN GBX CARDINAL HEALTH UNKJP DRAIN NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention