BEUDAMED
    FDA Adverse Event Other Summary report: N

    12FR 20CM MAHKR TLC KIT SGT EXT X5

    MDR report key: 1772206 · Received July 22, 2010

    Report

    Report Number
    1317749-2010-00199
    Event Type
    Other
    Date Received
    July 22, 2010
    Report Date
    June 10, 2009
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(6) 2010. 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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. BECAUSE OF FUMBLING OF A PATIENT, THE SILICONE EXTENSION SEPARATED FROM THE WHITE PLASTIC OF THE CATHETER ITSELF. THE SITE STARTED BLEEDING AND THERE WAS A HAZARD FOR AN AIR ASPIRATION. THE PATIENT DID NOT DEVELOP AN AIR EMBOLISM. IT IS UNCLEAR IF THE CATHETER WAS REPLACED AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12FR 20CM MAHKR TLC KIT SGT EXT X5 HEMODIALYSIS CATHETER MPB COVIDIEN 8888340629 901459

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other