BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME RT 15FR 19CM KIT

    MDR report key: 4220947 · Received November 3, 2014

    Report

    Report Number
    3009211636-2014-00139
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    August 15, 2014
    Report Date
    October 10, 2014
    Manufacturer
    COSTA RICA
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. NO CHANGES IN THE PROCESS WERE IDENTIFIED TO BE RELATED WITH THIS EVENT. THE PRODUCT SAMPLE RETURNED CONSISTED OF ONE 15 FR TAL PALINDROME RT CATHETER, 19 CM IMPLANT LENGTH, AND 39 CM OVERALL LENGTH. THE CATHETER WAS CUT APPROXIMATELY 3 CM BELOW THE HUB AND IT CAME INSIDE A GENERIC PLASTIC BAG. VISUAL INSPECTION WAS PERFORMED AND A CRACK WAS FOUND ON THE RED ADULT ADAPTER, IN THE THREAD AREA. THE BLUE ADULT ADAPTER DID NOT PRESENT ANY ISSUES. BASED ON 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. OVER TIGHTENING THE CATHETER CONNECTION CAN CRACK SOME ADAPTERS. THE ISSUE EXPERIENCED WAS NOT NOTED PRIOR TO USE. THE ADAPTER WAS MORE LIKELY DAMAGED DURING USE. THE MOST PROBABLE ROOT CAUSE IS LIKELY DUE TO OVER TIGHTENING AS EXCESSIVE FORCE COULD HAVE BEEN THE CAUSE OF THE DAMAGE. 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% VISUAL INSPECTION DURING PRODUCTION, WHICH WOULD IDENTIFY CRACKED ADAPTERS 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 THE USER NOTICED MICROBUBBLES IN THE CIRCUIT DURING CONNECTION. THE CATHETER WAS APPLIED ON (B)(6) 2014. ANOTHER CATHETER WAS USED. THE PATIENT LOST BLOOD. HEMOGLOBIN VALUE ON (B)(6) 2014: 12,9G/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703532 PALINDROME RT 15FR 19CM KIT DIALYSIS CATHETER MSD COSTA RICA 8888541019 306619X

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR