BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION COMPONENT

    MDR report key: 7392437 · Received April 3, 2018

    Report

    Report Number
    3006425876-2018-00231
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 5, 2018
    Report Date
    March 29, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    PMA / PMN Number
    K103658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SNAPLOCK ADAPTER WITH NO RELEVANT FINDINGS. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED SAMPLE. THE RETURNED SNAPLOCK ADAPTER WAS FUNCTIONALLY TESTED BY SCREWING THE DUST CAP ON AND OFF THE SNAPLOCK ADAPTER. THE DUST CAP FIT TYPICALLY ONTO THE SNAPLOCK ADAPTER WITH NO ISSUES. 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 OTHER REMARKS: 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). THE REPORTED COMPLAINT OF THE SNAPLOCK ADAPTER CAP NOT TIGHTENING CORRECTLY COULD NOT BE CONFIRMED THROUGH FUNCTIONAL TESTING OF THE RETURNED SNAPLOCK ADAPTER. THE DUST CAP COULD BE SCREWED ON AND OFF TYPICALLY WITH NO ISSUES. ALSO, 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 · 1

    IT WAS REPORTED THAT THE USER TRIED TO TIGHTEN THE CAP OF SNAPLOCK ADAPTOR, BUT HE COULD NOT. IT WAS REPORTED THAT ONLY THE SNAPLOCK ADAPTOR WAS REPLACED BY A NEW ONE AT FIRST, BUT IT HAS BEEN CONFIRMED THAT CATHETER WAS ALSO REMOVED AND REPLACED A NEW ONE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER TRIED TO TIGHTEN THE CAP OF SNAPLOCK ADAPTOR, BUT HE COULD NOT. IT WAS REPORTED THAT ONLY THE SNAPLOCK ADAPTOR WAS REPLACED BY A NEW ONE AT FIRST, BUT IT HAS BEEN CONFIRMED THAT CATHETER WAS ALSO REMOVED AND REPLACED A NEW ONE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237093 EPIDURAL CATHETERIZATION COMPONENT ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. 71F17E2166

    Patients

    Seq Age Sex Outcome Treatment
    1