BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 19/36 KIT W/ SLOT

    MDR report key: 4121524 · Received September 26, 2014

    Report

    Report Number
    3009211636-2014-00097
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    COSTA RICA
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THERE ARE NO NON-CONFORMANCES RELATED TO THE REPORTED ISSUE. THE PRODUCT SAMPLE RETURNED CONSISTED OF ONE ARTERIAL EXTENSION WITH ITS ADULT RED ADAPTER. AFTER VISUAL INSPECTION, THE EXTENSION WAS NOTICED CUT ON THE BASE OF THE SILICONE TUBING STRAIN RELIEF. DURING FUNCTIONAL TESTING (UNDERWATER TEST) THE ARTERIAL EXTENSION DID NOT SHOW BUBBLES. THE EVENT DESCRIPTION STATES THAT THERE WAS CRACK IN THE Y JUNCTION AND WAS FOUND DURING DIALYSIS TREATMENT. HOWEVER; BASED ON THE SAMPLE EVALUATION, THE REPORTED ISSUE WAS NOT CONFIRMED SINCE THE HUB AND CATHETER TUBING WERE NOT RETURNED. AS PER THE INSTRUCTIONS FOR USE, IT IS NECESSARY TO PERFORM A VISUAL INSPECTION BEFORE USING THE DEVICE. 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 PRODUCT WAS TESTED PRIOR TO USE, INDICATING THAT NO ISSUES WERE DETECTED PRIOR TO INSERTION. THEREFORE; THE DEVICE WAS MORE LIKELY DAMAGED DURING USE. BASED ON THE AVAILABLE INFORMATION, THE PROBABLE ROOT CAUSE IS MORE LIKELY DUE TO OVER BENDING OR EXCESSIVE FORCE. 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)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIAYLSIS CATHETER. THE CUSTOMER STATES THAT THERE WAS CRACK IN THE Y JUNCTION. THE CRACK WAS FOUND DURING DIALYSIS TREATMENT. THE PRODUCT WAS TESTED PRIOR TO USE. THE CATHETER WAS PULLED AND REPLACED WITH A NEW ONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602051 PALINDROME 19/36 KIT W/ SLOT DIALYSIS CATHETER MSD COSTA RICA 8888145014 229906X

    Patients

    Seq Age Sex Outcome Treatment
    1