BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW RA CATH SET: 20 GA X 1-3/4IN

    MDR report key: 25081827 · Received May 5, 2026

    Report

    Report Number
    9680794-2026-00347
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 8, 2026
    Report Date
    April 10, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    OFB
    UDI-DI
    00801902002730
    PMA / PMN Number
    K021120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, "DURING PREPARATION PRIOR TO THE ARTERIAL LINE PROCEDURE, THE GUIDEWIRE KINKED AND COULD NOT BE ADVANCED." THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70609 ARROW RA CATH SET: 20 GA X 1-3/4IN WIRE GUIDE CATHETER OFB ARROW INTERNATIONAL LLC 14F25D0181 00801902002730

    Patients

    Seq Age Sex Outcome Treatment
    1