BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JP CHANNEL DRAIN 10MM, FULL FLUTES

    MDR report key: 17961686 · Received October 18, 2023

    Report

    Report Number
    1423537-2023-00997
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    September 14, 2023
    Report Date
    December 1, 2023
    Manufacturer
    DEGANIA SILICONE LTD.
    Product Code
    KGZ
    UDI-DI
    10885380182518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    NO SAMPLE OR PHOTO WERE PROVIDED FOR EVALUATION THEREFORE THE SUPPLIER WAS UNABLE TO DETERMINE ROOT CAUSE FOR THE REPORTED ISSUE. THE BATCH RECORD FOR LOT NUMBER P22114035 WAS MANUFACTURED ON 4/24/2023 WITH AN EXPIRATION DATE OF 4/24/2028. IN-PROCESS CONTROLS CONTAINS TENSILE STRENGTH TEST OF EVERY BATCH OF THE DRAINS. THE BATCH PASSED TENSILE STRENGTH TEST (TEAR TEST) IN THE CONNECTION AREA. ALL THE RESULTS WERE HIGHER THAN MINIMUM REQUIREMENT. CARDINAL HEALTH WILL CONTINUE TO MONITOR AND TREND ALL SIMILAR REPORTED PRODUCT RELATED ISSUES.

    Description of Event or Problem · 0

    THE DRAIN TUBE BROKE WHEN THE SURGEON WAS REMOVING IT FROM THE PATIENT. IT LEFT ABOUT A 5" PIECE INSIDE THE PATIENT REQUIRING PATIENT TO BE RETURNED TO SURGERY FOR REMOVAL. THE PATIENT WAS RETURNED TO SURGERY FOR REMOVAL AND ADMINISTERED MEDICATION FOR ANESTHESIA AND RECOVERY. HE WAS DISCHARGED IN STABLE CONDITION TO SKILLED NURSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618021 JP CHANNEL DRAIN 10MM, FULL FLUTES ACCESSORIES, CATHETER KGZ DEGANIA SILICONE LTD. JP-2214 P22114035 10885380182518

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other