BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 23/40KT VT

    MDR report key: 3931609 · Received April 14, 2014

    Report

    Report Number
    1317749-2014-00197
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 10, 2014
    Manufacturer
    COVIDIEN
    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 ASSEMBLED PALINDROME 14.5FR WITH SLOTS HEPARIN COATING AND ANTIMICROBIAL SLEEVE CATHETER. AFTER A FUNCTIONAL INSPECTION, A HOLE ON THE JUNCTION BETWEEN THE HUB AND THE ANTI-MICROBIAL SLEEVE WAS FOUND. DURING THE UNDERWATER TEST, BUBBLES WERE DETECTED COMING OUT BELOW THE HUB FROM THE LUMEN WHICH CORRESPONDS TO THE VENOUS EXTENSION. THE LUMEN CORRESPONDING TO THE ARTERIAL EXTENSION DID NOT SHOW BUBBLES DURING THE TEST. AS PER THE INSTRUCTIONS FOR USE, IT IS NECESSARY TO PERFORM A VISUAL INSPECTION BEFORE USING THE DEVICE. THE INSTRUCTIONS STATE; DO NOT USE THE CATHETER IF IT APPEARS DAMAGED OR DEFECTIVE. THE CATHETER TUBING CAN TEAR WHEN SUBJECTED TO EXCESSIVE FORCE OR ROUGH EDGES. INSPECT THE CATHETER FREQUENTLY FOR NICKS, SCRAPES, AND CUTS WHICH COULD IMPAIR ITS PERFORMANCE. THE EVENT DESCRIPTION STATES THAT THE CATHETER WAS PULLED AND REPLACED ON (B)(6) 2014. IT IS NOTED THAT THE DEVICE WAS IN USE AND NO ISSUES WERE FOUND PRIOR INSERTION, BUT MORE LIKELY THE DEVICE WAS DAMAGED DURING USAGE. BASED ON THE AVAILABLE INFORMATION, THE PROBABLE ROOT CAUSE IS THAT THE LEAK COULD BE CAUSED MORE LIKELY DUE TO OVER BENDING OR EXCESSIVE FORCE. THIS COMPLAINT WAS RECEIVED ON 10/14/2014, THEREFORE IT CAN BE NOTED THAT THE LOT INVOLVED WAS MANUFACTURED BEFORE THE EXPECTED IMPLEMENTATION DATE OF ACTIONS RELATED TO A CORRECTIVE AND PREVENTIVE ACTION (CAPA) DATED 10/31/2014.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS NOT PROVIDED. WITHOUT THE LOT NUMBER, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. WITHOUT THE SAMPLE, IT IS NOT POSSIBLE TO DETERMINE A CONFIRMED ROOT CAUSE OF THIS ISSUE. SHOULD THE SAMPLE BE RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. 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. THIS INFORMATION WILL BE UTILIZED FOR TRACKING AND TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTION.

    Description of Event or Problem · 1

    DURING THE 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 A LEAK AT Y JUNCTION. THE CATHETER WAS INITIALLY PLACED IN RIGHT JUGULAR. THE PHYSICIAN DECIDED TO PULL AND REPLACE THE CATHETER ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226618 PALINDROME SAPPHIRE 23/40KT VT DIALYSIS CATHETER MSD COVIDIEN 8888145048C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR