BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENCKHOFF CATH (10)

    MDR report key: 2170859 · Received June 22, 2011

    Report

    Report Number
    1317749-2011-00188
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CATHETER WAS IMPLANTED ON (B)(6) 2009. THE LEAKAGE WAS FOUND ON THE TITANIUM JOINTS OF THE PERITONEAL DIALYSIS STRAIGHT CATHETER ON (B)(6) 2011 AND WAS CLAMPED. THE NEXT DAY, THE DAMAGED PART WAS SNIPPED OFF AND CHANGED INTO NEW TITANIUM JOINT AND EXTERIOR SHORT TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENCKHOFF CATH (10) PERITONEAL DIALYSIS CATHETER FJS COVIDIEN 8888423103 905805

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK