BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENCKHOFF CATH T202

    MDR report key: 4192380 · Received October 22, 2014

    Report

    Report Number
    3009211636-2014-00123
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 15, 2014
    Manufacturer
    COSTA RICA
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE WAS RECEIVED WITHIN A GENERIC PLASTIC BAG. IT CONSISTED OF ONE SECTION OF QUINTON PERITONEAL CATHETER, 2 CUFFS. THE STRAIGHT STRIPE TUBING WAS CUT IN TWO PARTS. VISUAL INSPECTION WAS PERFORMED AND BOTH WALLS OF THE TUBING WERE EXAMINED, IT WAS FOUND THAT THE WALL IS THINNER ON ONE SIDE. ADDITIONALLY A HOLE WAS FOUND IN THE TUBING, NEAR TO THE CUT AREA, THIS HOLE IS LOCATED IN THE THINNER PART OF TUBING. TWO FACTORS WERE IDENTIFIED TO PROBABLY CONTRIBUTE TO THE REPORTED EVENT. FIRST, THE EXTRUSION MACHINE COULD HAVE IMPROPER SETUP PARAMETERS, WRONG DIE SET / PIN - BUSHING AND PULL WHICH CAUSE WALL THICKNESS TOO SMALL. SECOND, THE OPERATOR COULD FAIL TO FOLLOW THE PROCEDURE AND THIS INSPECTION WOULD BE FAILED. HOWEVER, SINCE NO LOT NUMBER WAS PROVIDED, THIS CANNOT BE CONFIRMED. AS STATED, THE SITUATIONS MENTIONED ABOVE ARE CONSIDERED CONTRIBUTORY FACTORS AND NO THE ROOT CAUSE, BECAUSE ALTHOUGH THEM, IT MUST BE NOTICED THAT THE DEVICE HAD THE CAPACITY TO FUNCTION AS INTENDED DURING AN IMPORTANT TIME QUANTITY. THEREFORE IT CAN BE CONCLUDED THAT THE DEVICE FAILED AND LEAKED PRIMARILY BECAUSE IT WAS USED FOR A LONG TIME AND NOT PARTICULARLY DUE TO THE WALL THICKNESS. THIS COMPLAINT HAS BEEN CONFIRMED. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS MISUSE (ABUSE), SINCE LEAK WAS FOUND AFTER 6 YEARS OF USE. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. PER PROCEDURE, QA PERFORMS SAMPLING INSPECTION DURING PRODUCTION, WHICH WOULD AVOID THESE EVENTS OCCURRING WITH THE CATHETERS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/22/2014. 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)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE WALL OF THE TUBE BECAME THINNER THAN BEFORE. THE CATHETER WAS IMPLANTED IN THE PATIENT FOR 6 YEARS. THE HOSPITAL FOUND THIS EVENT BECAUSE THE CATHETER HAD A LEAKAGE PROBLEM. THE LEAKAGE WAS FOUND UNDER THE INTRAPERITONEAL AND CAUSED THE SOLUTION LEAKAGE WITHIN THE BODY. AFTER THE SURGERY TO REMOVE THE CATHETER, THE NURSE FOUND THE WALL OF TUBE BECAME THINNER WITH LEAKED. THE DEVICE WAS PULLED AND REPLACED WITH A NEW ONE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671735 TENCKHOFF CATH T202 DIALYSIS CATHETER MSD COSTA RICA 8888411405 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1