BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW EPIDURAL NEEDLE KIT17 GA. X 3-1/2"

    MDR report key: 4891449 · Received July 6, 2015

    Report

    Report Number
    1036844-2015-00283
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 11, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE KIT AND THE SALINE AMPULE WITH NO RELEVANT FINDINGS. THE TRAY CONFIGURATION FOR THIS KIT, ASK-05500-KPR REV. 3, WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE SALINE AMPULE IS LOCATED IN ITS OWN CAVITY, SEPARATED FROM OTHER COMPONENTS. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS PROVIDED FOR ANALYSIS. A DHR REVIEW WAS PERFORMED ON THE KIT AND THE SALINE AMPULE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE POTENTIAL CAUSE OF A BROKEN AMPULE IN THE TRAY COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE SAMPLE. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE AMPULE WAS BROKEN IN THE KIT. NO PATIENT/USER INJURY REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE AMPULE WAS BROKEN IN THE KIT. NO PATIENT/USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436121 ARROW EPIDURAL NEEDLE KIT17 GA. X 3-1/2" EPIDURAL NEEDLE KIT OGE ARROW INTERNATIONAL INC. 23F15C1227

    Patients

    Seq Age Sex Outcome Treatment
    1