BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR URETHANE UMB CATH

    MDR report key: 4186074 · Received October 20, 2014

    Report

    Report Number
    3009211636-2014-00105
    Event Type
    Malfunction
    Date Received
    October 20, 2014
    Report Date
    September 22, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. THE CUSTOMER REPORTED A LEAK OF THE UVC CATHETER. NO PATIENT INJURY WAS REPORTED. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. THE CUSTOMER COULD NOT IDENTIFY THE EXACT LOT# OF THE CATHETER USED, BUT PROVIDED POSSIBLE LOT # OF 1415700130. THE POSSIBLE LOT INVOLVED WITHIN THIS COMPLAINT WAS MANUFACTURED ON 08/20/2014 AFTER IMPLEMENTATION OF SPECIAL 510K#K130725. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS MISUSE (LEAK COULD BE CAUSED DUE TO OVER BENDING OR EXCESSIVE FORCE). HOWEVER WITHOUT THE SAMPLE, THIS CANNOT BE CONFIRMED. 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. ALSO UNDER THE...

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT THE UVC DEVELOPED A LEAK. THERE WAS NO PATIENT HARM. THE CUSTOMER FURTHER REPORTS THAT THEY CHANGED OUT THE CATHETER AND HAD DIFFICULTY GETTING ANOTHER ONE BACK IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666577 3.5FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333

    Patients

    Seq Age Sex Outcome Treatment
    1