BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JP 3-SPRING RES W/10FR PVC DRAIN/TRO

    MDR report key: 2946183 · Received February 6, 2013

    Report

    Report Number
    1423537-2013-00007
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 6, 2013
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR INVESTIGATION. AS THE COMPLAINT SAMPLE WAS NOT RETURNED, A COMPREHENSIVE FAILURE ANALYSIS WAS NOT POSSIBLE. THE LOT NUMBER WAS ALSO NOT PROVIDED AND WITHOUT IT WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORDS TO DETERMINE IF ANY DEVIATIONS TOOK PLACE DURING THE MANUFACTURING OF THIS DEVICE. A REVIEW OF THE PRODUCT'S SPECIFICATION FOUND THE 10FR DRAIN HAS A BREAK STRENGTH REQUIREMENT OF A MINIMUM OF 9 POUNDS, WHICH IS SUFFICIENT TO WITHSTAND NORMAL HANDLING STRESS. BASED ON THE ABOVE ANALYSIS AND INFORMATION AVAILABLE, WE ARE NEITHER ABLE TO IDENTIFY THE ROOT CAUSE OF THE DRAIN BREAKAGE NOR CONFIRM IT WAS DUE TO A MANUFACTURING DEFECT AT THIS POINT IN TIME. NO SPECIFIC CORRECTIVE ACTION HAS BEEN IMPLEMENTED AT THIS POINT AS THE ROOT CAUSE(S) COULD NOT BE IDENTIFIED. THE CUSTOMER IS ADVISED TO REFER TO THE DIRECTIONS FOR USE (DFU) THAT IS PACKAGED ALONG WITH THE PRODUCT FOR PRECAUTIONS ON DRAIN HANDLING AS FOLLOW: 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. DRAINS OR TUBING SHOULD NOT BE HANDLED WITH ANY INSTRUMENTS. THIS CAN LEAD TO TEARING, WARPING OR WEAKENING AND SUBSEQUENT BREAKAGE OF THE DRAIN. 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 FOR CONTINUOUS IMPROVEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A HEMOVAC WOUND DRAIN WAS IMPLANTED INTO PATIENT AFTER A LEFT TOTAL KNEE ARTHROPLASTY PROCEDURE. ON (B)(6) 2013, THE DRAIN BROKE WHILE BEING REMOVED FROM THE (B)(6) FEMALE PATIENT. PATIENT WAS SENT TO SURGERY TO HAVE THE REMAINING PORTION REMOVED FROM BODY. ADDITIONALLY: CUSTOMER STATED, "THE PATIENT ID NUMBER (B)(6). THE SURGERY TO REMOVE THE DRAIN FOUND THE DRAIN WAS WRAPPED/CAUGHT IN THE MOVEABLE PART OF THE JOINT, BUT NOT IN THE CEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49646 JP 3-SPRING RES W/10FR PVC DRAIN/TRO WOUND DRAIN AND RESERVOIR GCY CARDINAL HEALTH SU130-402D NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention