BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 28/45KT VT

    MDR report key: 1064587 · Received June 23, 2008

    Report

    Report Number
    1317749-2008-00094
    Event Type
    Malfunction
    Date Received
    June 23, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 27, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS BEGINNING OF DIALYSIS; THE CUSTOMER REPORTS THAT AS THE ARTERIAL LINE WAS OPENED AND AFTER THE BANDAGE THAT COVERED THE JUNCTURE BETWEEN THE END AND THE CAP WAS REMOVED THE TREATING NURSE SAW THAT THE SILICONE TUBING THAT COVERS THE DISTAL ARTERIAL END WAS SWEATING. THE PT WAS NOT ABLE TO RECEIVE DIALYSIS IN 2008. DIALYSIS OCCURRED IN THE NEXT DAY. A 10% PROVIDONE IODINE GAUZE WAS APPLIED TO THE CATHETER INCISION, VANCOMYCIN 1MG IV, VITAMIN K (PT ANTI-COAGULATED) WERE ADMINISTERED. A SECOND CLAMP WAS PLACED ON THE CATHETER NEAR THE DISTAL ARTERIAL END AND PT WENT HOME. THE NEXT DAY, THE CATHETER WAS REPLACED. THE CATHETER HAD BEEN IN PLACE SINCE ABOUT THREE MONTHS PRIOR. THE PT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME SAPPHIRE 28/45KT VT DIALYSIS CATHETER MPB TYCO HEALTHCARE/KENDALL 8888145049 731781

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK