BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR P.U.R. UMBIL CATH X10

    MDR report key: 4483948 · Received February 4, 2015

    Report

    Report Number
    3009211636-2015-00047
    Event Type
    Malfunction
    Date Received
    February 4, 2015
    Date of Event
    January 14, 2015
    Report Date
    January 21, 2015
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 2/04/2015. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED INDICATING THAT THERE WAS NO QUALITY ISSUES ASSOCIATED WITH THIS DEFECT MODE. THERE ARE NO NON- CONFORMANCES RELATED TO THE REPORTED ISSUE. THE PRODUCT SAMPLE WAS NOT RETURNED AND NO PHOTOS WERE RECEIVED. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A THOROUGH FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE DEFECT AND ROOT CAUSE ANALYSIS. THIS COMPLAINT WILL BE REOPENED AND UPDATED ACCORDINGLY IF THE PRODUCT SAMPLE IS RETURNED. THE CATHETER WAS REPORTED TO HAVE FUNCTIONED AS INTENDED FOR APPROXIMATELY 2 WEEKS, THEREFORE IT IS CONSIDERED THAT MORE LIKELY, THE DEVICE WAS DAMAGED DURING THAT TIME. 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. THE LOT INVOLVED WITHIN THIS COMPLAINT WAS MANUFACTURED ON 5/3/2013 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...

    Description of Event or Problem · 1

    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 SPECIAL 510K#K130725, A DESIGN CHANGE WAS IMPLEMENTED TO INCREASE THE LENGTH OF THE STRAIN RELIEF ON THE LUER HUB OF THE SINGLE LUMEN UVC CATHETERS. THIS CHANGE IS EXPECTED TO REDUCE THE STRESS AND LIKELIHOOD OF KINKING IN THE AREA MOST LIKELY TO BE EXPOSED TO ALCOHOL. THIS CHANGE WAS EXECUTED IN MAY 2014. ADDITIONALLY 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. MANUFACTURING PERFORMS 100% LEAK TESTING AT THE FINAL STAGE OF PRODUCTION, WHICH WOULD IDENTIFY THIS ISSUE IN THE CATHETER ASSEMBLY. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 01/21/2015 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER STATES THAT A FISSURE(CRACK) WAS FOUND ON THE CATHETER AND A NEW UNIT WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82533 3.5FR P.U.R. UMBIL CATH X10 UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 312302X

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA