BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR P.U.R. UMBIL CATH X10

    MDR report key: 4235955 · Received November 7, 2014

    Report

    Report Number
    3009211636-2014-00147
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 24, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE SEE THE INVESTIGATION FINDINGS BELOW: THE PRODUCT SAMPLE RETURNED WAS RECEIVED WITHIN A GENERIC PLASTIC BAG AND CONSISTED OF AN URETHANE UMBILICAL CATHETER. AFTER VISUAL INSPECTION, A HOLE WAS FOUND BELOW THE STRAIN RELIEF, AT THE BASE OF THE LUER FITTING. THE HOLE FOUND ON THE CATHETER CAUSES A GROSS LEAK THAT SHOULD BE CERTAINLY IDENTIFIED DURING MANUFACTURING OPERATIONS (100% LEAK TEST). THEREFORE IT CAN BE CONCLUDED THAT THE DEVICE WAS MORE LIKELY DAMAGED DURING USE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THE LOT INVOLVED WITHIN THIS COMPLAINT WAS MANUFACTURED 06/04/2013 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 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..

    Additional Manufacturer Narrative · 1

    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)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT A LEAK WAS NOTICED AT THE LEVEL OF THE CATHETER CONNECTION. CATHETER ABLATION WAS PERFORMED AND A PERIPHERAL PERFUSION WAS APPLIED TO ALLOW INTRAVENOUS FEEDING.

    Description of Event or Problem · 1

    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 (B)(4) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717073 3.5FR P.U.R. UMBIL CATH X10 UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 315802X

    Patients

    Seq Age Sex Outcome Treatment
    1