BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET: 19 GA

    MDR report key: 9559756 · Received January 7, 2020

    Report

    Report Number
    3006425876-2020-00064
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 27, 2019
    Report Date
    January 3, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE CATHETER WAS BLOCKED. THE CUSTOMER RETURNED ONE SNAPLOCK ADAPTOR W/CLIP AND ONE EPIDURAL CATHETER (REFERENCE ATTACHED FILES (B)(4)). THE RETURNED COMPONENTS WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED SNAPLOCK ADAPTOR REVEALED THE SNAPLOCK APPEARS TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. VISUAL EXAMINATION OF THE RETURNED CATHETER REVEALED THE CATHETER APPEARS USED. BIOLOGICAL MATERIAL CAN BE SEEN BETWEEN THE INNER COILS AND ADHESIVE MATERIAL CAN BE SEEN ON THE OUTER EXTRUSION OF THE CATHETER. A FUNCTIONAL FLOW TEST WAS PERFORMED ON THE RETURNED SAMPLE PER (B)(4) SECTION 7.8; REV. 7. THE RETURNED EPIDURAL CATHETER WAS INSERTED FROM THE PROXIMAL END INTO THE RETURNED SNAPLOCK ADAPTOR UNTIL IT BOTTOMED OUT AND THE SNAPLOCK ADAPTOR WAS CLOSED. THE COMPONENTS WERE CONFIRMED TO BE SECURED BY TUGGING GENTLY. THE SNAPLOCK ADAPTOR 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 8.0ML/MIN (C05180), WHICH IS WITHIN THE SPECIFICATION OF 1ML/MIN. NO BLOCKAGES WERE FOUND. THE REPORTED COMPLAINT OF THE CATHETER BEING BLOCKED 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 PATIENT WAS ANESTHETIZED DURING PAINLESS DELIVERY, THE CATHETER WAS BLOCKED DURING THE PUNCTURE. AFTER THE CATHETER WAS PULLED OUT FOR TEST, THE CATHETER WAS STILL OBSTRUCTED, RESULTING IN A FAILED EPIDURAL PUNCTURE. THE DOCTOR REPLACED IT WITH ANOTHER CATHETER TO COMPLETE THE TREATMENT. PATIENT IS FINE.

    Additional Manufacturer Narrative · 1

    QN#: (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 PATIENT WAS ANESTHETIZED DURING PAINLESS DELIVERY, THE CATHETER WAS BLOCKED DURING THE PUNCTURE. AFTER THE CATHETER WAS PULLED OUT FOR TEST, THE CATHETER WAS STILL OBSTRUCTED, RESULTING IN A FAILED EPIDURAL PUNCTURE. THE DOCTOR REPLACED IT WITH ANOTHER CATHETER TO COMPLETE THE TREATMENT. PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20600 EPIDURAL CATHETERIZATION SET: 19 GA ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 71F18M2046

    Patients

    Seq Age Sex Outcome Treatment
    1