BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 23/40 KIT W/ SLOT

    MDR report key: 3974915 · Received June 11, 2014

    Report

    Report Number
    1317749-2014-00266
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE SEE SECTION FOR INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    PRODUCT SAMPLE RETURNED CONSISTED OF ONE PALINDROME 23/40 KIT W/ SLOT CATHETER. THE POSSIBLE CAUSES WERE IDENTIFIED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THERE ARE NOT NCR RELATED TO THE REPORTED ISSUE. THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS (B)(4). AFTER VISUAL INSPECTION, A HOLE WAS FOUND ON THE JOINT OF THE CATHETER BELOW THE HUB. DURING UNDERWATER TEST (FUNCTIONAL TEST), BUBBLES WERE DETECTED COMING OUT BELOW THE HUB, FROM THE LUMEN WHICH CORRESPONDS TO THE ARTERIAL EXTENSION. THE LUMEN CORRESPONDING TO THE VENOUS EXTENSION DID NOT SHOW BUBBLES DURING THE TEST. MORE INFORMATION WAS REQUESTED TO THE CUSTOMER AND NO ADDITIONAL EVIDENCE WAS PROVIDED FOR THIS ANALYSIS. AS PER THE INSTRUCTIONS FOR USE, IT IS NEEDED TO PERFORM A VISUAL INSPECTION BEFORE USING THE DEVICE, SINCE STATES: DO NOT USE THE CATHETER OR COMPONENTS IF THEY APPEAR DAMAGED OR DEFECTIVE AND CONTINUES, CATHETER TUBING CAN TEAR WHEN SUBJECTED TO EXCESSIVE FORCE OR ROUGH EDGES. INSPECT THE CATHETER FREQUENTLY FOR NICKS SCRAPES, CUTS, ETC., WHICH COULD IMPAIR ITS PERFORMANCE. THE EVENT DESCRIPTION DECLARES THAT THE CATHETER FUNCTIONED AS INTENDED DURING ONE YEAR, BUT MORE LIKELY BASED ON THE ISHIKAWA DIAGRAM, THE DEVICE WAS DAMAGED DURING THAT TIME. THIS DEFECT HAS NOT BEEN CONFIRMED. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS MISUSE (LEAK COULD BE CAUSED DUE TO OVER BENDING OR EXCESSIVE FORCE). NO ADDITIONAL ACTIONS ARE REQUIRED. THE LOT INVOLVED WITHIN THIS COMPLAINT WAS MANUFACTURED ON 04/08/1201, BEFORE THE EXPECTED IMPLEMENTATION DATE OF ACTIONS RELATED TO CAPA. AFTER A QSEAS EVALUATION, IT WAS DEFINED THAT THIS EVENT IS BEING HANDLED THROUGH THIS CAPA AND NO ADDITIONAL ACTIONS ARE REQUIRED. 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. AS 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)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THERE WAS CRACK ON THE CATHETER Y JUNCTION. THE CATHETER HAS BEEN IMPLANTED IN THE PT FOR ABOUT ONE YEAR. THE SURGEON REMOVED AND REPLACED THE CATHETER WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343727 PALINDROME 23/40 KIT W/ SLOT DIALYSIS CATHETER MSD COVIDIEN 8888145015 109849

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK