BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW RA CATH KIT: 20 GA X 12 CM

    MDR report key: 24895610 · Received April 16, 2026

    Report

    Report Number
    9680794-2026-00354
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 30, 2026
    Report Date
    March 30, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    OFB
    UDI-DI
    30801902117367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED "ON INSERTION WIRE KINKED SO SECOND KIT OPENED AND THE WIRE KINKED AS WELL UNABLE TO PLACE LINE". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ASSOCIATE MDR NUMBERS INCLUDE: 9680794-2026-00305.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606028 ARROW RA CATH KIT: 20 GA X 12 CM WIRE, GUIDE, CATHETER OFB ARROW INTERNATIONAL LLC 33F25K0199 30801902117367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED