BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 5497760 · Received March 14, 2016

    Report

    Report Number
    3006425876-2016-00060
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Date of Event
    February 16, 2016
    Report Date
    February 17, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND SNAPLOCK ADAPTER WITH NO RELEVANT FINDINGS. THE CUSTOMER RETURNED ONE EPIDURAL CATHETER AND ONE SNAPLOCK ADAPTER FOR INVESTIGATION, REFERENCE FILE PIC_INP1900043908. THE RETURNED COMPONENTS WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED CATHETER REVEALED THAT THE CATHETER APPEARS TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. VISUAL EXAMINATION OF THE RETURNED SNAPLOCK ADAPTER REVEALED THAT THE SNAPLOCK APPEARS TYPICAL. NO DEFECTS OR ANOMALIES WERE OBSERVED. AN ATTEMPT TO INSERT THE RETURNED CATHETER INTO THE RETURNED SNAPLOCK ADAPTER WAS MADE. THE CATHETER WILL NOT THREAD PAST THE OPENING IN THE SNAPLOCK ADAPTER CAP. A SECOND ATTEMPT WAS MADE USING THE RETURNED CATHETER WITH A LAB INVENTORY SNAPLOCK ADAPTER. THE CATHETER WOULD INSERT INTO THE LAB INVENTORY SNAPLOCK ADAPTER WITH NO DIFFICULTY INDICATING THAT THERE ARE NO FUNCTIONAL ISSUES FOUND WITH THE RETURNED CATHETER. OTHER REMARKS: SPECIFICATIONS PER GRAPHIC K-05520-004B REV. 02 WERE REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE REPORTED COMPLAINT OF INABILITY TO INSERT THE CATHETER INTO THE SNAPLOCK ADAPTER WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE INNER DIAMETER OF THE CAP FOR THE SNAPLOCK ASSEMBLY WAS FOUND TO BE OUT OF SPECIFICATION AS A RESULT OF EXCESSIVE ADHESIVE RESIDUE CIRCUMVOLVING THE INNER RIM OF THE CAP. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT ISSUE IS MANUFACTURING RELATED. NONCONFORMANCE, (B)(4), HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGED EVENT: THE SNAPLOCK ADAPTOR COULD NOT CONNECT WITH THE CATHETER. AS A RESULT, A NEW KIT WAS USED, THE FIRST CATHETER WAS REMOVED AND A NEW ONE WAS INSERTED. THERE WAS NO HARM TO THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE SNAPLOCK ADAPTOR COULD NOT CONNECT WITH THE CATHETER. AS A RESULT, A NEW KIT WAS USED, THE FIRST CATHETER WAS REMOVED AND A NEW ONE WAS INSERTED. THERE WAS NO HARM TO THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154693 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. 71F15B0615

    Patients

    Seq Age Sex Outcome Treatment
    1