BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMADUCT, 10FR 3/4 DUCTED W/TROCAR

    MDR report key: 1516444 · Received October 15, 2009

    Report

    Report Number
    1423507-2009-00103
    Event Type
    Other
    Date Received
    October 15, 2009
    Date of Event
    August 27, 2009
    Report Date
    October 15, 2009
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# 1090265. UNFORTUNATELY, THE ACTUAL PRODUCT INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR OUR INVESTIGATION. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED IN ORDER TO DETERMINE POSSIBLE CAUSES FOR THE INCIDENT REPORTED AND REVEALED THAT ALL OPERATIONS WERE PERFORMED ACCORDING TO ESTABLISHED PROCEDURES. THERE ARE SYSTEMS IN PLACE FOR RANDOM INSPECTION OF THE UNITS FOR SURFACE IMPERFECTIONS, SPECIFICALLY CUTS, NICKS OR TEARS. THE MINIMUM TENSILE STRENGTH SPECIFICATION FOR THE TUBING IS 750 PSI. THE DHR OF THIS TUBING DEMONSTRATED TENSILE STRENGTH RESULTS OF A MINIMUM OF 989 PSI IN MANUFACTURING TESTING PERFORMED. INSPECTION RECORDS FOR RAW MATERIAL USED TO EXTRUDE THE TUBING WERE REVIEWED AND INDICATED THAT ALL TEST RESULTS ARE WITHIN SPECIFICATION LIMITS, INCLUDING TENSILE AND TEAR TESTS. THE LOT NUMBERS REPORTED WERE MANUFACTURED ON (B)(6) 2009 RESPECTIVELY. WHILE THIS ANALYSIS CANNOT CONCLUSIVELY DETERMINE THE CAUSE FOR FAILURE, THE DATA REVIEWED DOES NOT LEAD US TO BELIEVE THAT THERE WAS AN INHERENT WEAKNESS IN THE MATERIAL ITSELF. WOUND DRAINS WILL PERFORM AS INTENDED AS LONG AS THEY ARE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IFU PROVIDES DETAILED INFORMATION REGARDING PRECAUTIONS FOR USING THESE PRODUCTS. WARNING/PRECAUTIONS: "DRAINS OR TUBING SHOULD NOT BE HANDLED WITH ANY INSTRUMENTS. THIS CAN LEAD TO TEARING, WARPING, OR WEAKENING AND SUBSEQUENT BREAKAGE OF THE DRAIN. DRAINS SHOULD BE PLACED AND REMOVED CAREFULLY BY HAND ONLY WITH A SLOW STEADY PRESSURE. EXCESSIVE FORCE MAY RESULT IN BREAKAGE." WE WILL CONTINUE TO MONITOR TRENDS.

    Description of Event or Problem · 1

    THERE WAS DAMAGE ON THE TUBE THAT WAS FOUND AFTER SURGERY. ACTUAL LOT # WAS NOT CONFIRMED; IT WAS EITHER #1090293 OR #1090265. THE DRAIN WAS REMOVED IMMEDIATELY AFTER FOUND AND THE PATIENT HAD RE-OPERATION TO HAVE ANOTHER DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMADUCT, 10FR 3/4 DUCTED W/TROCAR WOUND DRAIN GCY CARDINAL HEALTH JP-HUR101 1090293

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention