BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW RA CATH SET: 20 GA X 1-1/2 IN

    MDR report key: 25221596 · Received May 19, 2026

    Report

    Report Number
    9680794-2026-00394
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 22, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    OFB
    UDI-DI
    00801902002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2026, "WHEN MEDICAL STAFF PERFORMED PREOPERATIVE INVASIVE ARTERIAL PUNCTURE ON THE PATIENT, THE RADIAL ARTERY WAS SUCCESSFULLY ACCESSED, YET NO BLOOD RETURN WAS OBSERVED. AFTER REMOVING THE ARTERIAL PUNCTURE CATHETER KIT, BLOCKAGE OF THE ARTERIAL PUNCTURE FLEXIBLE TUBING WAS CONFIRMED. FLUSHING WITH A NORMAL SALINE SYRINGE WAS INEFFECTIVE. THE MEDICAL TEAM HAD TO REPLACE THE ENTIRE ARTERIAL PUNCTURE CATHETER KIT AND PERFORM A SECOND PUNCTURE." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT, ASIDE FROM PATIENT DISCOMFORT RELATED TO A SECOND PUNCTURE. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING REPLACEMENT WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471919 ARROW RA CATH SET: 20 GA X 1-1/2 IN WIRE GUIDE CATHETER OFB ARROW INTERNATIONAL LLC 14F24H0116 00801902002761

    Patients

    Seq Age Sex Outcome Treatment
    1