BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 11.5FX16 CE MAHURKAR

    MDR report key: 1062812 · Received June 18, 2008

    Report

    Report Number
    1282497-2008-00013
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: JUNE 18, 2008. AN INVESTIGATION IS UNDER WAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN 2008, THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. CUSTOMER REPORTS THAT A MAHURKAR DIALYSIS CATHETER WAS PLACED IN A PATIENT IN THE RECOVERY ROOM IN THE OPERATING ROOM. THE PHYSICIAN WHO DID THE INSERTION STATED THAT THERE WERE NO DIFFICULTIES AT ALL WHEN HE WAS DOING THE INSERTION AND THAT THE CATHETER WAS "OKAY". THE CATHETER WENT IN WITHOUT DIFFICULTY PER CUSTOMER. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT AFTER THE INSERTION AND THERE THE CATHETER WAS FOUND TO BE IN TWO PIECES OUTSIDE THE PATIENT. THEY PLACED A NEW MAHURKAR DIALYSIS CATHETER IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT 11.5FX16 CE MAHURKAR DIALYSIS CATHETER MSD TYCO HEALTHCARE/KENDALL 8830415003 723626

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK