BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 19/36KT VT

    MDR report key: 4120862 · Received September 26, 2014

    Report

    Report Number
    3009211636-2014-00094
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 25, 2014
    Manufacturer
    COSTA RICA
    Product Code
    MSD
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE POSSIBLE CAUSES WERE IDENTIFIED. NO LOT NUMBER WAS PROVIDED, THEREFORE, IT IS NOT POSSIBLE TO PERFORM A DHR REVIEW. PRODUCT SAMPLE RETURNED CONSISTED OF ONE ASSEMBLED 14.5 FR DUAL LUMEN HEMODIALYSIS CATHETER WITH LASER SLOTS. AFTER VISUAL INSPECTION, A HOLE WAS FOUND BELOW THE Y JUNCTION. DURING UNDERWATER TEST (FUNCTIONAL TEST), BUBBLES WERE DETECTED COMING OUT BELOW THE HUB, FROM THE LUMEN WHICH CORRESPONDS TO THE VENOUS EXTENSION. 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 OVER BENDING OR EXCESSIVE FORCE). 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% 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.

    Additional Manufacturer Narrative · 1

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

    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 A LEAK IN Y JUNCTION. AS THE RESULT, THE PATIENT EXPERIENCED BLOOD LEAKAGE. THE DEVICE WAS PULLED AND REPLACED ON (B)(4) 2014. NO PATIENT INJURY. THE DWELL TIME OF THE CATHETER IN THE PATIENT: 3 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602045 PALINDROME SAPPHIRE 19/36KT VT DIALYSIS CATHETER MSD COSTA RICA 8888145057

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR