BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW EPIDURAL CATHETERIZATION KIT NRFIT

    MDR report key: 22130789 · Received June 3, 2025

    Report

    Report Number
    3006425876-2025-00492
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 7, 2025
    Report Date
    May 7, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    OGE
    UDI-DI
    10801902196788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Additional Manufacturer Narrative · 0

    QN(B)(4). THE REPORTED COMPLAINT OF THE LOR SYRINGE BEING BROKEN WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. THE CUSTOMER RETURNED ONE 5ML GLASS LOR SYRINGE NRFIT AND LIDSTOCK. VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED THE LOR SYRINGE APPEARED TO BE CRACKED ON THE SHOULDER OF THE BARREL. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL KIT AND THE LOR SYRINGE WITH NO RELEVANT FINDINGS. SINCE IT CANNOT BE DETERMINED WHEN THE SYRINGE BECAME DAMAGED, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THE GLASS LOR SYRINGE WAS FOUND BROKEN UPON OPENING THE PACKAGE. THEREFORE, A NEW KIT WAS USED INSTEAD."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THE GLASS LOR SYRINGE WAS FOUND BROKEN UPON OPENING THE PACKAGE. THEREFORE, A NEW KIT WAS USED INSTEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358581 ARROW EPIDURAL CATHETERIZATION KIT NRFIT ANESTHESIA CONDUCTION CATHETER OGE ARROW INTERNATIONAL LLC 71F24D0050 10801902196788

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED| NOT REPORTED