BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIT WOUND EVAC 1/8 DBL 400MI

    MDR report key: 1847247 · Received September 20, 2010

    Report

    Report Number
    1423507-2010-00040
    Event Type
    Other
    Date Received
    September 20, 2010
    Date of Event
    August 13, 2010
    Report Date
    September 16, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DHR SHOWED NO DEVIATIONS DURING THE MANUFACTURING OF THE AFFECTED LOT. THERE WERE NO REWORKS DURING PRODUCTION AND ALL OPERATORS WERE QUALIFIED. DURING 100% IN-PROCESS VISUAL INSPECTION OF THE PVC DRAINS, A TOTAL OF 10EA WERE CULLED OUT FOR EMBEDDED PARTICLES AND PUNCHED-OUT MATERIAL STILL CLINGING TO DRAIN HOLES OUT OF A TOTAL OF 4650EA USED. THERE WERE NO INCIDENTS OF TORN OR BROKEN DRAIN. SAMPLING INSPECTION OF DRAIN OUTER AND INNER DIAMETER MET DRAWING SPECIFICATIONS. AS THE COMPLAINT SAMPLE WAS NOT RETURNED, A COMPREHENSIVE FAILURE ANALYSIS WAS NOT POSSIBLE. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THE PRODUCT WAS MADE TO SPECIFICATIONS. WE ARE UNABLE TO IDENTIFY THE ROOT CAUSE OF THE DRAIN FRACTURING AT THIS POINT IN TIME. PER THE DIRECTIONS FOR USE, IT HAS BEEN WARNED THAT DRAIN BREAKAGE MAY OCCUR UNDER THE FOLLOWING SCENARIOS: EXCESSIVE FORCE DURING REMOVAL PROCESS; HANDLING THE DRAIN WITH ANY INSTRUMENTS WHICH CAN LEAD TO TEARING, WARPING OR WEAKENING AND SUBSEQUENT BREAKAGE OF THE DRAIN; NICK, CUT, TEAR OR OTHERWISE DAMAGE THE DRAIN DURING PLACEMENT AND REMOVAL OF THE DRAIN; LEAVING THE DRAIN IMPLANTED FOR ANY PERIOD OF TIME AS IT ALLOWS FOR TISSUE INGROWTH AROUND THE DRAIN AND INTO THE HOLES, WHICH MAY CAUSE BREAKAGE ON REMOVAL.

    Description of Event or Problem · 1

    A PVC DRAIN GOT FRACTURED DURING REMOVAL PROCEDURE AND ABOUT 5 CM PIECES REMAINED IN THE PT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT WOUND EVAC 1/8 DBL 400MI WOUND DRAIN KIT GCY CARDINAL HEALTH SU130-402D 091101D2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention