BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 23/40KT VT

    MDR report key: 4192598 · Received October 22, 2014

    Report

    Report Number
    3009211636-2014-00064
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 25, 2014
    Manufacturer
    COVIDIEN MANUFACTURING
    Product Code
    MSD
    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 PRODUCT SAMPLE RETURNED CONSISTED OF ONE PALINDROME SAPPHIRE 23/40KT VT CATHETER. THE POSSIBLE CAUSES WERE IDENTIFIED. THE DHR WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THERE ARE NO NCRS RELATED TO THE REPORTED ISSUE. VISUAL INSPECTION REVEALED A HOLE ON THE JOINT OF THE CATHETER WITH THE HUB. DURING UNDERWATER TEST (FUNCTIONAL TEST), BUBBLES WERE DETECTED 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 AS MISUSE (LEAK COULD BE CAUSED MORE LIKELY DUE TO THE USE OF AN IMPROPER CLEANING AGENT). PER PROCEDURE, MANUFACTURING PERFORMS 100% LEAK TESTING AT THE FINAL STAGE OF PRODUCTION, WHICH WOULD IDENTIFY THIS ISSUE 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)(4) 2014 THAT A CUSTOMER HAS AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THERE WAS A BREAK IN Y-JUNCTION. AS THE RESULT, THE PATIENT EXPERIENCED BLOOD LEAKAGE. THE CATHETER WAS IMPLANTED IN THE PATIENT ON (B)(6) 2012. THE DEVICE WAS PULLED AND REPLACED ON (B)(6) 2014. NO PATIENT INJURY. THE DWELL TIME OF THE CATHETER IN THE PATIENT: 2 YEARS WITH 5 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672067 PALINDROME SAPPHIRE 23/40KT VT DIALYSIS CATHETER MSD COVIDIEN MANUFACTURING 8888145048 110410

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR