BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 8274006 · Received January 24, 2019

    Report

    Report Number
    3006425876-2019-00081
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    January 10, 2019
    Report Date
    January 10, 2019
    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 SNAPLOCK ADAPTER AND EPIDURAL CATHETER WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE CATHETER WAS DIFFICULT TO INSERT INTO THE SNAPLOCK. THE CUSTOMER RETURNED ONE OPENED KIT (REFERENCE ATTACHED FILES INP20029592. THE SNAPLOCK ADAPTER AND CATHETER WERE REMOVED FROM THE RETURNED KIT. THE RETURNED COMPONENTS WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED SNAPLOCK ADAPTER REVEALED THAT THE SNAPLOCK ADAPTER 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. THE OUTER DIAMETER (OD) OF THE RETURNED CATHETER MEASURED 1.04MM (CALIPER C05155) WHICH IS WITHIN THE SPECIFICATION OF A MAXIMUM OF 1.115MM PER GRAPHIC KZ-05400-002; REV 9. THE INNER DIAMETER (ID) OF THE CAP CATHETER ADAPTER OF THE RETURNED SNAPLOCK ADAPTER MEASURED 0.053" (C05157) WHICH IS WITHIN THE SPECIFICATION OF 0.052"-0.055" PER GRAPHIC K-05520-004B; REV 2. FUNCTIONAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLE. THE RETURNED EPIDURAL CATHETER WAS INSERTED FROM THE PROXIMAL END INTO THE RETURNED SNAPLOCK ADAPTER. THE CATHETER WOULD INSERT INTO THE RETURNED SNAPLOCK ADAPTER UNTIL IT BOTTOMED OUT, BUT WITH MUCH DIFFICULTY AS COMPARED TO INSERTING THE RETURNED CATHETER INTO A LAB INVENTORY SNAPLOCK ADAPTER. THE CAP CATHETER ADAPTER AND COLLAR OF THE RETURNED SNAPLOCK ADAPTER WERE REMOVED. NO VISIBLE DEFECT OR ANOMALIES WERE OBSERVED. SPECIFICATIONS PER GRAPHIC KZ-05400-002; REV. 9 AND K-05520-004B; REV 2 WERE REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE ROOT CAUSE FOR THIS COMPLAINT INVESTIGATION COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND THE CONDITION OF THE SAMPLE RECEIVED. IT SHOULD BE NOTED, SNAPLOCK ADAPTER (K-05520-005B) IS NO LONGER MANUFACTURED BY TELEFLEX. IT WAS REPLACED WITH SNAPLOCK ASSEMBLY (CA-000010-19). THE REPORTED COMPLAINT OF THE CATHETER BEING DIFFICULT TO INSERT INTO THE SNAPLOCK ADAPTER WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. THE RETURNED CATHETER WOULD FULLY INSERT INTO THE RETURNED SNAPLOCK ADAPTER, HOWEVER, WITH MUCH DIFFICULTY AS COMPARED TO INSERTING INTO A LAB INVENTORY SNAPLOCK ADAPTER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SNAPLOCK ADAPTER AND EPIDURAL CATHETER WITH NO RELEVANT FINDINGS. ALSO, THE RETURNED CATHETER OD AND THE CAP CATHETER ADAPTER ID WERE FOUND TO BE WITHIN SPECIFICATION. THEREFORE, BASED UPON THE INFORMATION PROVIDED AND THE CONDITION OF THE SAMPLE RECEIVED, THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER WAS UNABLE TO INSERT THE CATHETER INTO SNAPLOCK ADAPTOR. THE SNAPLOCK AND CATHETER WERE REPLACED.

    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 USER WAS UNABLE TO INSERT THE CATHETER INTO SNAPLOCK ADAPTOR. THE SNAPLOCK AND CATHETER WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67980 EPIDURAL CATHETERIZATION SET EPIDURAL ANESTHESIA KIT OGE ARROW INTERNATIONAL INC. 71F17L1982

    Patients

    Seq Age Sex Outcome Treatment
    1