BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 7694285 · Received July 17, 2018

    Report

    Report Number
    3006425876-2018-00429
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 18, 2018
    Report Date
    June 19, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND SNAPLOCK ADAPTER WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THAT THE SNAPLOCK ADAPTER DISCONNECTED FROM THE CATHETER. THE CUSTOMER RETURNED ONE SNAPLOCK ADAPTER, ONE FLAT FILTER, AND ONE EPIDURAL CATHETER (REFERENCE ATTACHED FILES (B)(4)). THE RETURNED COMPONENTS WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. THE SNAPLOCK ADAPTER APPEARS USED AS ADHESIVE CAN BE SEEN ON THE EXTERIOR OF THE SNAPLOCK ADAPTER. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE FLAT FILTER APPEARS TYPICAL WITH NO DEFECTS OR ANOMALIES OBSERVED. VISUAL EXAMINATION OF THE RETURNED EPIDURAL CATHETER REVEALED THAT THE CATHETER APPEARS USED. BIOLOGICAL MATERIAL CAN BE SEEN BETWEEN THE CATHETER COILS AND ADHESIVE RESIDUE IS PRESENT ON THE CATHETER BODY EXTERIOR. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. A FUNCTIONAL LEAK TEST WAS PERFORMED ON THE RETURNED SAMPLE PER MRQ 000017 SECTION 7.5; REV. 7. THE RETURNED EPIDURAL CATHETER WAS INSERTED FROM THE PROXIMAL END INTO THE RETURNED SNAPLOCK ADAPTER UNTIL IT BOTTOMED OUT AND THE SNAPLOCK ADAPTER WAS CLOSED. THE COMPONENTS WERE CONFIRMED TO BE SECURED BY TUGGING GENTLY. THE SNAPLOCK ADAPTER WAS CONNECTED TO THE LAB LEAK TESTER (C05176) AND THE PRESSURE WAS INCREASED TO 10 PSI TO ESTABLISH FLOW. THE DISTAL END OF THE CATHETER WAS CAPPED OFF AND THE PRESSURE WAS INCREASED TO 25 PSI FOR 30 SECONDS. NO LEAKS WERE DETECTED AND THE COMPONENTS REMAINED SECURED. A FUNCTIONAL SPO TEST WAS THEN PERFORMED PER MRQ 000017 SECTION 7.7; REV 7. THE PROXIMAL END OF THE EPIDURAL CATHETER WAS RE-INSERTED INTO THE SNAPLOCK ADAPTER UNTIL IT BOTTOMED OUT AND THE SNAPLOCK ADAPTER WAS LOCKED. THE COMPONENTS WERE CONFIRMED TO BE SECURED BY TUGGING GENTLY ON THE CATHETER. THE COMPONENTS WERE THEN LEFT TO SIT FOR 72 HOURS IN THE LOCKED POSITION. AFTER 72 HOURS, THE SNAPLOCK ADAPTER WAS CONFIRMED TO HAVE REMAINED SECURELY LOCKED WITH THE CATHETER INSERTED. NO FUNCTIONAL ISSUES WERE FOUND (REFERENCE FILES (B)(4)). NO CORRECTIVE ACTION NEEDED AT THIS TIME SINCE NO FUNCTIONAL ISSUES WERE FOUND WITH THE RETURNED SNAPLOCK ADAPTER. THE REPORTED COMPLAINT OF THE SNAPLOCK ADAPTER DISCONNECTING FROM THE CATHETER COULD NOT BE CONFIRMED THROUGH FUNCTIONAL TESTING OF THE RETURNED SNAPLOCK ADAPTER. THE SNAPLOCK ADAPTER WAS SECURED TO THE EPIDURAL CATHETER AND PASSED THE FUNCTIONAL TESTS PERFORMED INCLUDING A SPONTANEOUS PARTIAL OPENING (SPO) TEST. THERE WAS NO PROBLEM FOUND WITH THE RETURNED SNAPLOCK ADAPTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER CAME OFF THE SNAPLOCK ADAPTER DURING USE ON A PATIENT. THEREFORE, A NEW DEVICE AND CATHETER INSERTED. NO PATIENT INJURY WAS REPORTED.

    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 CAME OFF THE SNAPLOCK ADAPTER DURING USE ON A PATIENT. THEREFORE, A NEW DEVICE AND CATHETER INSERTED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535727 EPIDURAL CATHETERIZATION SET EPIDURAL ANESTHESIA KIT OGE ARROW INTERNATIONAL INC. 71F17G0014

    Patients

    Seq Age Sex Outcome Treatment
    1