BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5 FR URETHANE UMB CATH

    MDR report key: 4120827 · Received July 28, 2014

    Report

    Report Number
    1317749-2014-00305
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    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 UVC CATHETER AT THE BASE OF THE LUER FITTING. 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 350479 (JULIAN LOT NUMBER 219107X). LOT 350479 WAS RELEASED ON 07/18/2012. THE DHR REVIEW INDICATED THAT THERE WAS NO QUALITY ISSUES ASSOCIATED WITH THIS DEFECT MODE. THE CUSTOMER REPORTED THAT THEIR PROTOCOL FOR CLEANING THE DEVICE INCLUDES THE USE OF CHLORAPREP WHICH CONTAINS ALCOHOL BASED PRODUCTS. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS MISUSE (LEAK COULD BE CAUSED DUE TO THE USE OF AN IMPROPER CLEANING AGENT). THE LOT INVOLVED WITHIN THIS COMPLAINT WAS MANUFACTURED ON 07/18/2012 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

    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. THE CUSTOMER REPORTS A LEAK JUST BELOW THE HUB WHERE THE CATHETER IS JOINED. CHLORAPREP WAS USED TO CLEAN THE SKIN AREA AND THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. IT WAS NOT DIFFICULT TO HANDLE THE CATHETER DURING INSERTION AND WAS NOT DIFFICULT TO SECURE. THE UVC WAS INSERTED (B)(4) 2014 IN THE ARTERIAL FOR CONTINUOUS USE. A 10 CC SYRINGE WITH SALINE WAS USED TO FLUSH THE LINE. CHLORAPREP CONTAINING ALCOHOL WAS USED TO CLEAN THE DEVICE. THE CATHETER TUBING WAS NOT BEING CLEANED. THE UVC WAS REMOVED ON (B)(4) 2014 AND WAS NOT REPLACED. THE PATIENT IS NO LONGER AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439900 3.5 FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 219107X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK