BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR URETHANE UMB CATH

    MDR report key: 4084835 · Received September 2, 2014

    Report

    Report Number
    3009211636-2014-00066
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 10, 2014
    Report Date
    August 12, 2014
    Manufacturer
    COVIDIEN MANUFACTURING SOLUTIONS SA
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE WAS RETURNED TO THE MANUFACTURING SITE FOR REVIEW. IT WAS FOUND THAT THERE WAS A HOLE IN THE CATHETER AT THE BASE OF THE LUER FITTING. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS MISUSE (LEAK COULD BE CAUSED MORE LIKELY DUE TO EXCESSIVE FORCE OR A SHARP OBJECT). THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THERE ARE NO NON-CONFORMANCES RELATED TO THE REPORTED ISSUE. THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS 1406900077; IT WAS RELEASED ON 05/09/14. THE DHR REVIEW INDICATED THAT THERE WAS NO QUALITY ISSUES ASSOCIATED WITH THIS DEFECT MODE. THE LOT INVOLVED WITHIN THIS COMPLAINT WAS MANUFACTURED ON 03/08/14 PRIOR TO IMPLEMENTATION OF SPECIAL 510K#K130725. UNDER SPECIAL 510K#K130725, COVIDIEN EXPANDED WARNINGS WITHIN THE INSTRUCTIONS FOR USE MANUAL OF THIS PRODUCT TO HIGHLIGHT THE CONCERN OF UVC CATHETER DAMAGE IN THE HUB AREA ASSOCIATED WITH THE USE OF ALCOHOL BASED DISINFECTANTS. THE INSTRUCTIONS FOR USE WERE REPLACED IN ALL STOCK, AND HOSPITALS WERE SENT A LETTER HIGHLIGHTING THIS ISSUE. IT MUST BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES: DO NOT USE INSTRUMENTS WITH SHARP OR ROUGH EDGES DIRECTLY ON THE CATHETER SINCE EVEN A MINOR CUT COULD TEAR OR BREAK THE CATHETER AND CONTINUES, DO NOT PINCH OR BEND THE CATHETER BACK TO TEMPORARILY OCCLUDE THE CATHETER. THIS CAUSES INCREASED STRESS ON THE CATHETER WHICH CAN LEAD TO A LEAK OR BREAK. DO NOT USE ALCOHOL, ACETONE, OR ALCOHOL CONTAINING ANTISEPTICS DIRECTLY ON THE CATHETER. CAREFULLY CHECK ANTISEPTIC SOLUTIONS FOR ALCOHOL OR ACETONE. THESE SUBSTANCES MAY CAUSE IRREVERSIBLE DAMAGE TO THE POLYURETHANE WHICH CAN LEAD TO A LEAK OR BREAK. ENSURE GLOVES OR OTHER SURFACES WHICH HAVE ALCOHOL ON THEM ARE COMPLETELY DRY BEFORE TOUCHING OR MANIPULATING THE CATHETER.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014. THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC)/. THE CUSTOMER REPORTS LEAKAGE 2CM JUST BELOW THE MOLDED STRAIN RELIEF ON THE EXTENSION. BETADINE WAS USED TO CLEAN THE SKIN AREA AND THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. IT WAS NOT DIFFICULT TO HANDLE DURING INSERTION. THE UVC WAS NOT DIFFICULT TO SECURE AND WAS SECURED WITH STERISTRIPS. THE UVC WAS INSERTED ON (B)(4) 2014 AT 2000 IN THE UMBILICAL ARTERY. THE UVC WAS IN CONTINUOUS USE. NS WITH HEPARIN, UNIT/ML WITH A 5ML SYRINGE WAS USED TO FLUSH THE LINE. THERE WAS NOTHING USED TO CLEAN THE DEVICE OR THE TUBING. THE UVC WAS REMOVED ON (B)(4) 2014 AT 2300 AND WAS NOT REPLACED. THE STATUS OF THE PT IS CRITICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532032 3.5FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER FOS COVIDIEN MANUFACTURING SOLUTIONS SA 8888160333 1406900077

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK