BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 19/36 KIT W/ SLOT

    MDR report key: 3221798 · Received July 2, 2013

    Report

    Report Number
    1317749-2013-00214
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. 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)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATED THAT CHRONIC DIALYSIS CATHETER WAS IMPLANTED ON (B)(6) 2013. ON (B)(6) 2013, DURING DIALYSIS, THE DOCTOR FOUND BUBBLES IN THE BLOOD ON THE ARTERIAL SIDE. HOWEVER, INVERTED GRAFTING THE VEIN, THERE WAS NO BUBBLE IN THE BLOOD. AFTER CHECKING AN X-RAY, THE CATHETER WAS FOUND TO BE IN THE RIGHT PLACE AND IT DID NOT INJURE THE AIR PASSAGE WAY. THERE WAS NO OBVIOUS CRACK FOUND IN THE CATHETER. THE PT POINTED OUT THAT THE GAUZE IN THE PAYUP OF EXTENSION CATHETER WAS ALWAYS EXUDED IN THESE TWO WEEKS. ON (B)(6) 2013, DURING DIALYSIS, THE ABOVE MENTIONED CONDITION HAPPENED AGAIN. IT WAS DIAGNOSED THAT THERE WAS A CRACK IN THE ARTERIAL SIDE ADAPTER. THE CATHETER WAS PULLED AND REPLACED. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300965 PALINDROME 19/36 KIT W/ SLOT DIALYSIS CATHETER MSD COVIDIEN 8888145014 224333X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK