BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 19/36 KIT W/ SLOT

    MDR report key: 4121685 · Received September 26, 2014

    Report

    Report Number
    3009211636-2014-00099
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 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

    THE POSSIBLE CAUSES WERE IDENTIFIED. THE DHR WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THERE ARE NO NCR RELATED TO THE REPORTED ISSUE. PRODUCT SAMPLE WAS NOT RETURNED. THE PHOTO PROVIDED BY CUSTOMER WAS CONSISTED OF ONE CATHETER WHERE SHOWS A HOLE BELOW THE HUB. MORE INFORMATION WAS REQUESTED TO THE CUSTOMER AND NO ADDITIONAL EVIDENCE WAS PROVIDED FOR THIS ANALYSIS. THIS COMPLAINT WILL BE REOPENED AND UPDATED ACCORDINGLY IF THE PRODUCT SAMPLE IS RETURNED. THIS DEFECT HAS BEEN CONFIRMED. THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW BUT THE IMAGE PROVIDED BY CUSTOMER CLEARLY SHOWS A HOLE BELOW THE HUB. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE CAN BE CONSIDERED AS MISUSE (LEAK COULD BE CAUSED MORE LIKELY DUE TO OVER BENDING OR EXCESSIVE FORCE). 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.

    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. NO CHANGES IN THE PROCESS WERE IDENTIFIED TO BE RELATED WITH THIS EVENT. THE PRODUCT SAMPLE WAS RECEIVED WITHIN A GENERIC PLASTIC BAG. IT CONSISTED OF ONE INCOMPLETE PALINDROME 14.5 FR DUAL LUMEN HEMODIALYSIS CATHETER, WITH LASER SLOTS. AFTER VISUAL INSPECTION, SIGNS OF USE WERE IDENTIFIED ON THE CATHETER BODY, THE CATHETER TUBING WAS CUT AT APPROXIMATELY 1 CM BELOW THE HUB AND ADDITIONALLY A HOLE WAS FOUND JUST BELOW THE HUB. DURING FUNCTIONAL TESTING (UNDERWATER 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. 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 THE PRODUCT WAS TESTED PRIOR TO USE, INDICATING THAT NO ISSUES WERE DETECTED PRIOR TO INSERTION. BASED ON THE AVAILABLE INFORMATION, THE PROBABLE ROOT CAUSE CAN BE THAT THE LEAK COULD BE CAUSED DUE TO OVER BENDING OR EXCESSIVE FORCE. THE LOT INVOLVED WITHIN THIS COMPLAINT WAS MANUFACTURED ON 10/23/12, BEFORE THE EXPECTED IMPLEMENTATION DATE OF ACTIONS RELATED TO A CORRECTIVE AND PREVENTIVE ACTION (CAPA). AFTER AN 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 A CRACK WAS FOUND AT THE Y JUNCTION OF THE CATHETER AND LEAKING BLOOD. THE PRODUCT WAS TESTED PRIOR TO USE. THE CATHETER WAS PULLED AND REPLACED WITH A NEW ONE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602332 PALINDROME 19/36 KIT W/ SLOT DIALYSIS CATHETER MSD COSTA RICA 8888145014 229906X

    Patients

    Seq Age Sex Outcome Treatment
    1