BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 11.5FX19.5 CE MAHURKAR

    MDR report key: 2890626 · Received November 21, 2012

    Report

    Report Number
    1317749-2012-00291
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 25, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING LOT ASSOCIATED WITH THIS COMPLAINT WAS 110380. THE DEVICE HISTORY RECORD REVIEW INDICATED THAT THERE WAS NO QUALITY ISSUES ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT SAMPLE WAS RECEIVED AT THE MANUFACTURING SITE FOR REVIEW. ONE (1) 11.5FR X 19.5 CM DUAL LUMEN CATHETER WITH CURVED EXTENSIONS WAS RETURNED. A CROSS SECTION OF THE RETURNED SAMPLE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE RETURNED SAMPLE WAS SUBJECTED TO A UNDERWATER LEAK TEST. THE DISTAL END OF THE CATHETER WAS CLAMPED AND AIR WAS INFUSED INTO EACH LUMEN TO CHECK FOR LEAKS. WHEN AIR WAS INFUSED INTO THE ARTERIAL LUMEN, NO BUBBLES WERE DETECTED. WHEN AIR WAS INFUSED INTO THE VENOUS LUMEN, BUBBLES WERE DETECTED. THE SAMPLE WAS PLACED ON THE OPTICAL MICROSCOPE FOR MAGNIFICATION AND INSPECTION WHICH REVEALED LEAKAGE AT THE HUB AND CATHETER JUNCTION WHERE THE SOURCE WAS IDENTIFIED AS FRACTURES IN THE FILLET (GLUE), WHICH ARE BELIEVED TO HAVE OCCURRED THROUGH USE. THIS COMPLAINT HAS BEEN CONFIRMED FOR LEAKAGE. HOWEVER, IT IS NOT CONSIDERED TO BE A MANUFACTURING RELATED ISSUE. THIS PRODUCT IS 100% INSPECTED DURING SEVERAL STAGES OF PRODUCTION. PER PROCEDURE, MANUFACTURING PERFORMS 100% PRESSURE TESTING ON THE CATHETER ASSEMBLIES WHICH WOULD IDENTIFY ANY LEAKAGE. THE COMPLAINT REPORT STATED THAT THE CATHETER WAS IN USE FOR APPROXIMATELY (B)(6). THIS WOULD INDICATE THAT THE DEVICE WAS FUNCTIONING DURING THAT TIME WITHOUT ISSUE, EVEN THOUGH THAT PERIOD OF USE EXCEEDS THE DESIGN LIFE AND THE STATED LIFE IN THE IFU. THE IFU (INSTRUCTIONS FOR USE) STATES: "RECOMMENDED THAT SUBCLAVIAN AND JUGULAR CATHETERS BE REPLACED EVERY 21 DAYS. DO NOT USE ACETONE, ALCOHOL OR ANY SOLUTION CONTAINING ALCOHOL ON ANY PART OF THE CATHETER. EXPOSURE TO THESE AGENTS MAY CAUSE CATHETER DAMAGE. ANY ONE OF THE FOLLOWING CAN BE USED: AQUEOUS-BASED POVIDONE-IODINE, CHLORHEXIDINE, AMUKIN 50 PERCENT, BACITRACIN OINTMENT, EXSEPT, HYDROGEN PEROXIDE, NEOSPORIN OR BACTROBAN CREAM". BASED ON THE INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS UNKNOWN. THE MOST PROBABLE CAUSE OF FAILURE IS DUE TO USAGE OF THE CATHETER EXCEEDING THE DESIGN LIFE OF (B)(6). THIS IS FURTHER SUPPORTED BY THE PRODUCT PERFORMANCE TESTING THAT WAS COMPLETED BY THE RESEARCH AND DEVELOPMENT TEAM ON UNUSED 11.5FR MAHURKAR CATHETER SAMPLES, WHICH PASSED ALL TESTING CRITERIA. A CORRECTIVE AND PREVENTIVE ACTION WILL NOT BE TAKEN AT THIS TIME. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER IS LEAKING AT THE BASE OF THE Y JUNCTION. THE CATHETER WAS IMPLANTED ON (B)(6) 2012 AND IN USE FOR (B)(6). AS A RESULT, THE CATHETER WAS PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT 11.5FX19.5 CE MAHURKAR DIALYSIS CATHETER MSD COVIDIEN 8813793013 110380

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK