BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 8603419 · Received May 13, 2019

    Report

    Report Number
    3006425876-2019-00361
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    May 6, 2019
    Report Date
    May 8, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE CATHETER COULD NOT BE FLUSH. THE CUSTOMER RETURNED ONE EMPTY KIT WITH A SNAPLOCK ASSEMBLY AND AN EPIDURAL CATHETER. THE RETURNED COMPONENTS WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED SNAPLOCK ASSEMBLY REVEALED THE SNAPLOCK APPEARS TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. VISUAL EXAMINATION OF THE RETURNED CATHETER REVEALED THAT THE CATHETER APPEARS TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. A FUNCTIONAL FLOW TEST WAS PERFORMED ON THE RETURNED SAMPLE PER AMRQ-000017 SECTION 7.8; REV. 7. THE RETURNED EPIDURAL CATHETER WAS INSERTED FROM THE PROXIMAL END INTO THE RETURNED SNAPLOCK ASSEMBLY UNTIL IT BOTTOMED OUT AND THE SNAPLOCK ASSEMBLY WAS CLOSED. THE COMPONENTS WERE CONFIRMED TO BE SECURED BY TUGGING GENTLY. THE SNAPLOCK ASSEMBLY WAS CONNECTED TO THE LAB LEAK TESTER (C05176) AND THE PRESSURE WAS INCREASED TO 10 PSI TO ESTABLISH FLOW. WATER COULD BE SEEN IMMEDIATELY EXITING THE DISTAL END OF THE CATHETER. THE FLOW RATE WAS MEASURED AT 9.0ML/MIN (C05180), WHICH IS WITHIN THE SPECIFICATION OF 1ML/MIN. NO BLOCKAGES WERE FOUND. THE REPORTED COMPLAINT OF THE CATHETER NOT BEING ABLE TO FLUSH COULD NOT BE CONFIRMED BASED ON THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED ISSUE. THE RETURNED COMPONENTS PASSED A FUNCTIONAL FLOW TEST AND MET FLOW RATE SPECIFICATIONS. THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE RETURNED SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER LUMEN COULD NOT BE FLUSHED. THE CATHETER WITH CONNECTOR IS NOT CONTINUOUS. PDK WAS ALREADY PLACED, WHEN TRYING TO APPLY THE TEST DOSE, A COMPLETE STOP WAS OBSERVED. THIS REMAINS UNCHANGED EVEN AFTER EMPTYING THE CATHETER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER LUMEN COULD NOT BE FLUSHED. THE CATHETER WITH CONNECTOR IS NOT CONTINUOUS. PDK WAS ALREADY PLACED, WHEN TRYING TO APPLY THE TEST DOSE, A COMPLETE STOP WAS OBSERVED. THIS REMAINS UNCHANGED EVEN AFTER EMPTYING THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399730 EPIDURAL CATHETERIZATION SET OGE ARROW INTERNATIONAL INC. 71F18L0716

    Patients

    Seq Age Sex Outcome Treatment
    1