BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR URETHANE UMB CATH

    MDR report key: 4186129 · Received October 20, 2014

    Report

    Report Number
    3009211636-2014-00106
    Event Type
    Malfunction
    Date Received
    October 20, 2014
    Report Date
    September 22, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE- RETURNED 3.5 FR URETHANE UMBILICAL CATHETER WAS REVIEWED. BASED ON THE MICROSCOPIC EXAMINATION, TWO HOLES IN THE CATHETER WERE FOUND AT THE BASE OF THE LUER FITTING. IT CAN BE NOTICED THAT THE DEVICE PRESENTS MATERIAL DEGRADATION EVIDENCE WHICH WAS MORE LIKELY CAUSED DUE TO THE USE OF AN IMPROPER CLEANING AGENT. THEREFORE, SINCE THE ISSUE WAS NOT IDENTIFIED DURING PREPARATION, AND THE HOLES FOUND ON THE CATHETER IS A GROSS LEAK THAT SHOULD BE IDENTIFIED DURING MANUFACTURING OPERATIONS (100% LEAK TEST), IT CAN BE CONCLUDED THAT THE DEVICE WAS MORE LIKELY DAMAGED DURING USE. THE SPECIFIC LOT FOR THIS COMPLAINT IS UNKNOWN; HOWEVER THE CUSTOMER PROVIDED THE LOT 1415700130 AS POSSIBLE REFERENCE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. 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...

    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 THAT THE UVC DEVELOPED A LEAK. THERE WAS NO PATIENT HARM. THE CUSTOMER FURTHER REPORTS THAT THEY CHANGED OUT THE CATHETER AND HAD DIFFICULTY GETTING ANOTHER ONE BACK IN.

    Description of Event or Problem · 1

    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 (B)(6) 2014. THE RETURNED SAMPLE¿S STRAIN RELIEF WAS MEASURED WITH THE VERTEX, AND IT WAS IDENTIFIED THAT ITS LENGTH IS 15.24 MM (NEW DESIGN LENGTH IS 18.5 MM). THIS COMPLAINTS LOT IS UNKNOWN AND THE EXACT MANUFACTURE DATE CANNOT BE DETERMINED. HOWEVER, BASED ON THE DIMENSIONAL INFORMATION ABOVE, IT CAN BE CONCLUDED THAT THIS DEVICE WAS MANUFACTURED BEFORE (B)(6) 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
    664889 3.5FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333

    Patients

    Seq Age Sex Outcome Treatment
    1