BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-Z COIL SPECIAL (OZ C CA2)

    MDR report key: 5144246 · Received October 12, 2015

    Report

    Report Number
    3009211636-2015-00408
    Event Type
    Malfunction
    Date Received
    October 12, 2015
    Date of Event
    September 22, 2015
    Report Date
    October 5, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/12/2015. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    A LOT NUMBER WAS NOT PROVIDED THEREFOR A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. THE PRODUCT SAMPLE CONSISTED OF ONE PD CATHETER. A VISUAL INSPECTION WAS PERFORMED AND IT CAN BE NOTED THAT THE DEVICE PRESENTED SIGNS OF USE (DIRT AND BLOOD RESIDUE). ADDITIONALLY, AROUND ONE OF THE CUFFS A TYPE OF MILDEW AND TAPE WAS OBSERVED. A CUT WAS FOUND ON THE CATHETER; APPROX. 2 CM BELOW THE CUFF. THIS APPEARS TO BE A CLEAN CUT. THE PRODUCT SPECIFICATION WAS REVIEWED CORRESPONDING TO THE LEAKAGE REPORTED ON THIS COMPLAINT. THE ACTUAL OCCURRENCE PERCENTAGE AND SEVERITY FOR THIS CONDITION WAS FOUND EQUAL THAN THE EXPECTED PER RISK MANAGEMENT DOCUMENT. BASED ON THE COMPLAINT DESCRIPTION THE CATHETER FUNCTIONED AS INTENDED FOR A PERIOD OF APPROXIMATELY 4 YEARS AND 4 MONTHS AND THE CATHETER PRESENTED SIGNS OF HEAVY USE WITHOUT ISSUES. THE CATHETER FUNCTIONED AS INTENDED FOR A PERIOD OF 4 YEARS AND 4 MONTHS APPROXIMATELY WITHOUT ISSUES; THEREFORE THIS POTENTIAL ROOT CAUSE IS RELATED TO PRODUCT USE. ACCORDING TO THE INSTRUCTIONS FOR USE CLEANING AGENTS, EXCESSIVE FORCE, AND SHARP OBJECTS MAY CAUSE THE CATHETER TO LEAK. 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. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    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 LEAKAGE OF THE CATHETER WAS NOTICED ON THE (B)(6). THIS RESULTED IN REZ. PERITONITIS AND SURGERY. THE PRODUCT WAS TESTED PRIOR TO USE. THE CATHETER EMERSION POINT WAS CLEANED WITH SANALIND (FRESENIUS). SURGERY WAS NECESSARY FOR REMOVAL OF THE CATHETER, PRIOR THE PATIENT HAD TWO INCIDENTS OF PERITONITIS. THE CATHETER WAS IMPLANTED ON THE (B)(6) 2011. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675204 O-Z COIL SPECIAL (OZ C CA2) DIALYSIS CATHETER MSD COVIDIEN 8888425710

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention