BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALINDROME 23/40 SLOT SPRT W/VT

    MDR report key: 1013312 · Received March 14, 2008

    Report

    Report Number
    1317749-2008-00048
    Event Type
    Other
    Date Received
    March 14, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 19, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER RN: "I VISITED THIS FACILITY ON MARCH 6TH 2008, I SPOKE WITH THE HEAD NURSE AT THE CLINIC WHO STATED THAT THIS PT HAS BEEN A NON COMPLIANT PT. FOLLOWING THE FIRST FLUOROSCOPY, ANOTHER FULL BODY WAS DONE BUT STILL NOTHING WAS FOUND." 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 THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER STATED: "PATIENT TOLD NURSES HE HAD A PROBLEM WITH THE CATHETER. HIS WIFE LIFTED DRESSING AND NOTICED A SMALL AMOUNT OF BLOOD. WHEN PT CAME TO DIALYSIS UNIT FOR TREATMENT WHILE USING HIS FISTULA, THE NURSE PULLED THE DRESSING OFF THE CATHETER INSERTION SITE AND SAW THAT THE CATHETER LAYING THERE. WHEN SUTURES WERE CUT OUT, A PIECE OF CATHETER FELL OUT. NURSE SAID CATHETER WAS SEVERED ABOUT HALF AN INCH BELOW CUFF AND EXIT SITE WAS HEALED OVER. IR CHECKED THE PT WITH FLUOROSCOPY AND THERE WAS NO SIGN OF THE CATHETER BEING IN THE PT'S BODY. CATHETER WAS NOT TUNNELED. PT'S LAST DIALYZED WITH THE CATHETER IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME 23/40 SLOT SPRT W/VT DIALYSIS CATHETER MPB TYCO HEALTHCARE/KENDALL 8888123404 731723

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK