BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR URETHANE UMB CATH

    MDR report key: 4092743 · Received September 9, 2014

    Report

    Report Number
    3009211636-2014-00070
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 12, 2014
    Manufacturer
    COVIDIEN MANUFACTURING SOLUTIONS SA
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE RETURNED FROM THE CUSTOMER CONSISTED OF ONE 3.5 FR URETHANE UMBILICAL CATHETER. AFTER VISUAL INSPECTION, NO VISIBLE ISSUES WERE FOUND. HOWEVER, DURING THE UNDERWATER TEST (FUNCTIONAL TEST), BUBBLES WERE DETECTED COMING OUT JUST BELOW THE STRAIN RELIEF. MAXIMIZED PHOTOS REVEALED A HOLE BELOW THE STRAIN RELIEF. THE EVENT DESCRIPTION IS THE ONLY PROVIDED INFORMATION AVAILABLE. IT INDICATES THAT THE CUSTOMER DID NOT NOTICE ANY LEAKING ON THE UVC UNTIL PLACEMENT. THEREFORE, SINCE THE ISSUE WAS NOT IDENTIFIED DURING PREPARATION OR DURING INSERTION, AND THE HOLE FOUND ON THE CATHETER IS A GROSS LEAK THAT WOULD HAVE BEEN IDENTIFIED DURING MANUFACTURING OPERATIONS (100% LEAK TEST), IT CAN BE CONCLUDED THAT THE DEVICE WAS MORE LIKELY DAMAGED DURING USE. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS MISUSE (LEAK COULD BE CAUSED MORE LIKELY DUE TO OVER BENDING OR EXCESSIVE FORCE). THIS CITED PRODUCT LOT NUMBER IS UNKNOWN AND THE EXACT MANUFACTURE DATE CANNOT BE DETERMINED. THE RETURNED SAMPLES STRAIN RELIEF WAS MEASURED AND IT WAS IDENTIFIED THAT ITS LENGTH IS 15.20 MM (NEW DESIGN LENGTH IS 18.5 MM). THEREFORE, IT CAN BE CONCLUDED THAT THIS DEVICE WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THE ACTIONS RELATED TO SPECIAL 510K- K#130725. 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 ACTION IS EXPECTED TO REDUCE THE STRESS AND LIKELIHOOD OF KINKING IN THE AREA MOST LIKELY TO BE EXPOSED TO ALCOHOL AND WAS EXECUTED IN (B)(6) 2014. ALSO 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. 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. THIS COMPLAINT WILL BE USED FOR TRENDING AND TRACKING PURPOSES.

    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 RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.

    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 THE CATHETER LEAKED AT THE HUB UPON INSERTION. THE CATHETER WAS REMOVED AND NO LONGER HAD ARTERIAL ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551704 3.5FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER FOS COVIDIEN MANUFACTURING SOLUTIONS SA 8888160333 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK`