BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 19/36 KT VT

    MDR report key: 3983564 · Received June 26, 2014

    Report

    Report Number
    1317749-2014-00284
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT SAMPLE CONSISTED OF ONE PALINDROME SAPPHIRE 19/36KT VT CATHETER. THE POSSIBLE CAUSES WERE IDENTIFIED. DHR WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THERE ARE NO NCR RELATED TO THE REPORTED ISSUE. VISUAL INSPECTION WAS PERFORMED AND A HOLE WAS FOUND ON THE JOINT OF THE CATHETER BELOW THE HUB. DURING UNDERWATER TEST (FUNCTIONAL TEST) BUBBLES WERE DETECTED; THEY WERE COMING OUT BELOW THE HUB, FROM THE LUMEN WHICH CORRESPONDS TO THE VENOUS EXTENSION. THE LUMEN RELATED TO THE ARTERIAL EXTENSION DID NOT SHOW BUBBLES DURING THE TEST. THIS DEFECT HAS BEEN CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE PROBABLE ROOT CAUSE CAN BE CONSIDERED MOST LIKELY AS MISUSE (LEAK COULD BE CAUSED DUE TO OVER BENDING OR EXCESSIVE FORCE) PER PROCEDURE, MANUFACTURING PERFORMS 100% PRESSURE TESTING AT THE FINAL STAGE OF PRODUCTION, WHICH WOULD IDENTIFY A LEAK IN THE CATHETER ASSEMBLY. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    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 THAT THERE WAS A LEAK AT Y-JUNCTION. THE CATHETER WAS PLACED IN (B)(6) 2012. THE PHYSICIAN PULLED AND REPLACED THE CATHETER ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374078 PALINDROME SAPPHIRE 19/36 KT VT DIALYSIS CATHETER MPB COVIDIEN 8888145057 127307X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK