BEUDAMED
    FDA Adverse Event Other Summary report: N

    JACKSON PRATT 7MM FLAT DRAIN FULL PERF

    MDR report key: 1503838 · Received October 1, 2009

    Report

    Report Number
    1423507-2009-00101
    Event Type
    Other
    Date Received
    October 1, 2009
    Date of Event
    July 29, 2009
    Report Date
    September 29, 2009
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, THE ACTUAL PRODUCT INVOLVED IN THIS INCIDENT WAS NOT RETURNED FOR OUR INVESTIGATION. ALSO, NO LOT NUMBER WAS REPORTED SO THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. WITHOUT THE CUSTOMER SAMPLE AND 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.

    Description of Event or Problem · 1

    DR. (B)(6) REPORTED THAT ON (B)(6) 2009, JACKSON PRATT DRAIN (B)(4) BROKE WHILE HE WAS ATTEMPTING TO REMOVE IT (BY HAND, NO INSTRUMENT). THE PT DID HAVE TO HAVE SURGERY TO REMOVE THE DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON PRATT 7MM FLAT DRAIN FULL PERF WOUND DRAIN GBX CARDINAL HEALTH SU130-1310 NG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention