BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 11.5FX19.5CM MAHURKAR

    MDR report key: 4861876 · Received June 23, 2015

    Report

    Report Number
    3009211636-2015-00280
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 16, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. THERE WERE NO SAMPLES RECEIVED FOR EVALUATION. BECAUSE A SAMPLE WAS NOT AVAILABLE FOR EVALUATION, A ROOT CAUSE ANALYSIS COULD NOT BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF THIS REPORTED ISSUE. IF SAMPLES ARE RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE RE-OPENED AND THE INVESTIGATION CONTINUED. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING). ADDITIONALLY, THE DEVICES ARE INSPECTED PER EXTENSION ASSEMBLY PROCEDURE IN ORDER TO DISCARD OCCLUSION. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THE CATHETER WAS BLOCKED AFTER THE FIRST TREATMENT AND THE PATIENT WAS UNABLE TO DO THE NEXT DIALYSIS TREATMENT. AFTER TAKING OUT THE CATHETER FROM THE PATIENT, THE CUSTOMER DISCOVERED THERE WAS A BLOOD CLOT AT THE SIDE SLOT, THEREFORE CAUSING THE BLOCKAGE OF THE CATHETER. THE CUSTOMER FOLLOWED NORMAL PRACTICE, INFUSED 2ML HEPARIN 5000IU IN EACH LUMEN AS LOCKING SOLUTION TO PREVENT CATHETER CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407131 KIT 11.5FX19.5CM MAHURKAR DIALYSIS CATHETER MSD COVIDIEN 8813793009 330405X

    Patients

    Seq Age Sex Outcome Treatment
    1