BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR P.U.R. UMBIL CATH X10

    MDR report key: 3965972 · Received June 3, 2014

    Report

    Report Number
    1317749-2014-00245
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 8, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. SEVERAL ATTEMPTS TO GATHER INFORMATION REGARDING THIS EVENT FROM THE CUSTOMER WERE MADE. NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED. WITH THE AVAILABLE INFORMATION RECEIVED TO DATE, THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS MISUSE (LEAKING DUE TO OVER BENDING OR EXCESSIVE FORCE DURING USE OF THE UVC CATHETER). HOWEVER WITHOUT THE CITED CATHETER, THIS CANNOT BE CONFIRMED. THE REPORTED LOT INVOLVED THIS COMPLAINT WAS MANUFACTURED ON 04/03/2013 PRIOR TO THE 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.

    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. THE CUSTOMER REPORTS THAT THE DEVICE WAS FITTED DURING THE MORNING BUT AT 8PM THE MEDICAL STAFF NOTICED A LEAK BETWEEN THE CONNECTING SITE OF THE DEVICE AND THE ADAPTOR. THE PT IS A BABY UNDER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324825 3.5FR P.U.R. UMBIL CATH X10 UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 308103X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK