BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED

    MDR report key: 4111048 · Received September 23, 2014

    Report

    Report Number
    2210968-2014-13557
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE SHARP EDGE OF THE RIB DAMAGED THE TUBING WHEN THE TUBING WAS PULLED AT AN ANGLE AND CAUSED THE BREAKAGE. THE PRODUCT DID MEET SPECIFICATION. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014 AND A DRAIN WAS USED. THE CONNECTION PART BETWEEN THE TROCAR AND THE DRAIN BROKE OFF. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592417 ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK J1400379

    Patients

    Seq Age Sex Outcome Treatment
    1