BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW EPIDURAL CATHETERIZATION SET

    MDR report key: 21505042 · Received March 3, 2025

    Report

    Report Number
    3006425876-2025-00181
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 7, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4) THE REPORTED COMPLAINT OF HAVING ISSUES WITH THE LOR SYRINGE COULD NOT BE CONFIRMED BASED ON THE SAMPLE RECEIVED. THE CUSTOMER RETURNED ONE OPENED KIT, AND THE VISUAL EXAMINATION OF THE SYRINGE REVEALED THAT THE SYRINGE APPEARS TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. THE RETURNED LOR SYRINGE PASSED FUNCTIONAL TESTING, INCLUDING A LEAK TEST. ALSO, THE RETURNED LOR SYRINGE WHEN COMPARED TO A LAB INVENTORY SYRINGE HAD COMPARABLE RESISTANCE WHEN SLIDING THE PLUNGER INTO THE BARREL OF THE SYRINGE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR SYRINGE WITH NO RELEVANT FINDINGS. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. BASED ON THE FUNCTIONAL TESTING, THERE WAS NO ISSUES FOUND WITH THE RETURNED SAMPLE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THERE WAS NO LOSS OF RESISTANCE ON THE LOR WHEN REACHING 10 ML WHILE SEARCHING FOR EPIDURAL SPACE CAUSING DURA MATTER BREACH. AFTER CHECKING THE LOR ON STOCK, IT WAS OBSERVED THAT THERE WAS NO LOSS OF RESISTANCE ON THE LOR WHEN REACHING THE 10 ML. THIS CAUSED DELAY IN TREATMENT AND INCREASE COST DUE TO REPLACEMENT." ASSOCIATED COMPLAINTS 3006425876-2025-00180, 3006425876-2025-00181 AND 3006425876-2025-00179.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THERE WAS NO LOSS OF RESISTANCE ON THE LOR WHEN REACHING 10 ML WHILE SEARCHING FOR EPIDURAL SPACE CAUSING DURA MATTER BREACH. AFTER CHECKING THE LOR ON STOCK, IT WAS OBSERVED THAT THERE WAS NO LOSS OF RESISTANCE ON THE LOR WHEN REACHING THE 10 ML. THIS CAUSED DELAY IN TREATMENT AND INCREASE COST DUE TO REPLACEMENT." ASSOCIATED COMPLAINTS 3006425876-2025-00180, 3006425876-2025-00181 AND 3006425876-2025-00179.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806692 ARROW EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL LLC IPN920760 71F24G0524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NO REPORTED| NO REPORTED