BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 5643030 · Received May 10, 2016

    Report

    Report Number
    3006425876-2016-00106
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    April 4, 2016
    Report Date
    April 13, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND SNAPLOCK ADAPTER WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE CATHETER DISCONNECTED FROM THE SNAPLOCK ADAPTER. THE CUSTOMER RETURNED ONE SNAPLOCK ADAPTER, ONE FLAT FILTER, AND A PIECE OF AN EPIDURAL CATHETER APPROXIMATELY 8.5CM (REFERENCE FILES (B)(4)). THE COMPONENTS WERE RECEIVED CONNECTED TOGETHER AND NO SNAPLOCK CLIP WAS RETURNED. THE COMPONENTS WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED SNAPLOCK ADAPTER REVEALED THAT THE SNAPLOCK APPEARS TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. VISUAL EXAMINATION OF THE RETURNED FLAT FILTER REVEALED THAT THE FLAT FILTER APPEARS TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. A FUNCTIONAL LEAK TEST WAS PERFORMED PER MRQ 000017 SECTION 6.5 REV. 5 USING A LAB INVENTORY CATHETER AND THE RETURNED SNAPLOCK ADAPTER. THE PROXIMAL END OF THE EPIDURAL CATHETER WAS INSERTED INTO THE SNAPLOCK ADAPTER UNTIL IT BOTTOMED OUT AND THE SNAPLOCK WAS CLOSED. THE COMPONENTS WERE CONFIRMED TO BE SECURED BY TUGGING GENTLY ON THE CATHETER. THE SNAPLOCK ADAPTER WAS THEN CONNECTED TO THE LAB LEAK OTHER REMARKS: TESTER (C05176) AND THE PRESSURE WAS INCREASED TO 10 PSI TO ESTABLISH FLOW. THE DISTAL END OF THE CATHETER WAS THEN CAPPED OFF AND THE PRESSURE WAS INCREASED TO 25 PSI FOR 30 SECONDS. NO LEAKS WERE DETECTED. A SECOND FUNCTIONAL TEST WAS PERFORMED USING THE RETURNED COMPONENTS PER MRQ 000017 SECTION 6.7 REV. 5 SPONTANEOUS PARTIAL OPENING. THE CATHETER WAS CONFIRMED TO BE SECURED IN THE SNAPLOCK ADAPTER AND THEN THE COMPONENTS WERE LEFT TO SIT FOR 72 HOURS IN THE CLOSED POSITION. AFTER 72 HOURS, THE SNAPLOCK ADAPTER WAS EXAMINED AND CONFIRMED TO REMAIN IN THE CLOSED POSITION WITH THE CATHETER SECURE. NO FUNCTIONAL ISSUES WERE FOUND WITH THE SNAPLOCK ADAPTER. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE RETURNED SAMPLE. THE REPORTED COMPLAINT OF A DISCONNECT BETWEEN THE SNAPLOCK ADAPTER AND THE EPIDURAL CATHETER COULD NOT BE CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE RETURNED COMPONENTS PASSED ALL FUNCTIONAL TESTING INCLUDING A SPONTANEOUS PARTIAL OPENING TEST. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND SNAPLOCK ADAPTER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE RETURNED SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED BUT THE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    REPORTED EVENT: IT WAS REPORTED THAT THE CONNECTOR LOOSENS TIME AFTER TIME AT THE CATHETER END. THE CATHETER WAS REPLACED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    REPORTED EVENT: IT WAS REPORTED THAT THE CONNECTOR LOOSENS TIME AFTER TIME AT THE CATHETER END. THE CATHETER WAS REPLACED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299127 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. 71F15G1079

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention