BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAHURKAR 13.5FRX19.5CM SE KIT

    MDR report key: 4132554 · Received October 1, 2014

    Report

    Report Number
    3009211636-2014-00047
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 22, 2014
    Manufacturer
    COSTA RICA, COVIDIEN MANUFACTURING
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 08/15/2014. AN INVESTIGATION SI 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 DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE SUTURE WING AND TUBE BODY WAS SEPARATED. THE SURGEON PULLED THE CATHETER OUT AND INSERTED A NEW CATHETER FOR THE PT. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    THE PRODUCT SAMPLE WAS NOT RETURNED AND NO PHOTOS WERE RECEIVED. THE EVENT DESCRIPTION ONLY STATES THAT THE SUTURE WING AND TUBE BODY WAS SEPARATED, AND NO LOT, SAMPLES OR PICTURES WERE PROVIDED FOR THIS ANALYSIS. THEREFORE IT IS NOT POSSIBLE TO DETERMINE THE REASON WHY THE SUTURE WING WAS DISCONNECTED FROM THE CATHETER. MORE INFORMATION WAS REQUESTED TO THE CUSTOMER AND NO ADDITIONAL EVIDENCE WAS PROVIDED. ALL THE POSSIBLE CAUSES WERE IDENTIFIED. NO LOT NUMBER WAS PROVIDED, THEREFORE, IT IS NOT POSSIBLE TO PERFORM A DHR REVIEW. THIS DEFECT HAS NOT BEEN CONFIRMED. THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS UNDETERMINABLE. 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. PER PROCEDURE, MANUFACTURING PERFORMS 100% SUTURE WING VISUAL INSPECTION 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611852 MAHURKAR 13.5FRX19.5CM SE KIT DIALYSIS CATHETER MPB COSTA RICA, COVIDIEN MANUFACTURING 8888135191 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR