BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14F X 36CM SPLIT STREAM

    MDR report key: 2102847 · Received May 3, 2011

    Report

    Report Number
    2518902-2011-00042
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 29, 2011
    Manufacturer
    MEDCOMP
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVAL. FROM THE DESCRIPTION OF THE EVENT THE FAILURE APPEARS TO BE ONE THAT HAS BEEN PREVIOUSLY INVESTIGATED. THE SPLIT STREAM CATHETER IS MANUFACTURED BY BONDING TWO LUMENS TOGETHER ALLOWING THE DISTAL PORTION OF THE LUMENS TO BE SEPARATED BY THE PHYSICIAN AS DEEMED APPROPRIATE. THE PROXIMAL PORTION OF THE LUMEN IS PERMANENTLY BONDED. SOME CATHETERS WERE DEVELOPING A SMALL HOLE IN THE LUMEN AT THE POINT WHERE THE LUMENS ARE PERMANENTLY BONDED TOGETHER. THE MFG PROCESS OF THE PERMANENTLY BONDED SECTION OF THE LUMENS INCLUDED A PEEL BACK STEP AFTER BONDING TO ASSURE THE CORRECT LOCATION OF THE BONDED SECTION. AFTER EVALUATING RETURNED SAMPLES IT WAS DETERMINED THAT THE PEEL BACK STEP MAY HAVE CONTRIBUTED TO THE WEAKENING OF LUMEN WALL TO THE POINT OF THAT HOLE MAY DEVELOPED OVER TIME IN THE FIELD. CHANGES HAVE BEEN IMPLEMENTED TO THE MFG PROCESS THAT WILL MINIMIZE THE SPREADING OF THE BONDING AGENT PASS THE PERMANENTLY BONDED SECTION THEREFORE ELIMINATING THE PEEL BACK STEP. A TRIAL WAS CONDUCTED USING THE IMPROVED PROCESS. ALL CATHETERS MET ALL ACCEPTANCE CRITERIA, VISUAL, DIMENSION, AND LEAK TEST. THE CATHETER INVOLVED IN THIS INCIDENT WAS MANUFACTURED PRIOR TO THE PROCESS CHANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS "LEAKAGE OF BLOOD, WHERE EXTENSIONS ARE CONNECTED TO THE CATHETER, DURING TREATMENT." NO ILL EFFECTS TO THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14F X 36CM SPLIT STREAM HEMODIALYSIS CATHETER LJT MEDCOMP SST36E. MART130

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention