BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 23/40KT VT

    MDR report key: 3940703 · Received April 22, 2014

    Report

    Report Number
    1317749-2014-00204
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 21, 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.

    Description of Event or Problem · 1

    THE RETURNED PRODUCT SAMPLE CONSISTED OF ONE ASSEMBLED CATHETER PALINDROME WHICH PRESENTED SIGNS OF USAGE (BLOOD RESIDUES). THE POSSIBLE CAUSES WERE IDENTIFIED. NO LOT NUMBER WAS PROVIDED, THEREFORE, IT IS NOT POSSIBLE TO PERFORM A DHR REVIEW. DURING VISUAL INSPECTION, A HOLE COULD BE APPRECIATED ON THE CATHETER JUST BELOW THE HUB. DURING UNDERWATER TEST (FUNCTIONAL TEST), BUBBLES WERE DETECTED COMING OUT BELOW THE HUB. 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). NO ADDITIONAL ACTION IS 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. 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 AFTER THE CATHETER WAS IMPLANTED IN THE PT FOR (B)(6), A LEAK WAS DISCOVERED AT THE Y-JUNCTION, DURING THE PROCESS OF HEMODIALYSIS. THE CATHETER WAS PULLED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242668 PALINDROME SAPPHIRE 23/40KT VT DIALYSIS CATHETER MSD COVIDIEN 8888145048 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR