BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK DY

    MDR report key: 4131570 · Received October 1, 2014

    Report

    Report Number
    3009211636-2014-00063
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 2014
    Manufacturer
    COVIDIEN MANUFACTURING
    Product Code
    FJS
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A UNK DIALYSIS CATHETER. THE CUSTOMER STATES THAT TWO MONCRIEF CATHETERS REPORTED AS HAVING AN ISSUE WITH INSERTION WHICH LEAD TO LEAKING AND INFECTION.

    Description of Event or Problem · 1

    THE PRODUCT SAMPLE WAS NOT RETURNED AND NO PHOTOS WERE RECEIVED. MORE INFORMATION WAS REQUESTED TO THE CUSTOMER AND NO ADDITIONAL EVIDENCE WAS PROVIDED FOR THIS ANALYSIS. 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 ATTRIBUTED TO THE USERS INSERTION/PLACEMENT METHOD EMPLOYED WHICH GENERATED ISSUES DURING THE PROCEDURE. HOWEVER WITHOUT THE SAMPLE, THIS CANNOT BE CONFIRMED. 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% VISUAL INSPECTION AT THE FINAL STAGE OF PRODUCTION, WHICH WOULD AVOID ISSUES 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
    612736 UNK DY UNK DY FJS COVIDIEN MANUFACTURING UNK DY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK