BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24766650 · Received April 2, 2026

    Report

    Report Number
    9680794-2026-00222
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 11, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    OFB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED "FTER INSERTION THE ART LINE AND USING THE WIRE, THE CANNULA WOULDNT PUSH OFF THE NEEDLE/WIRE EVEN THOUGH CLEARLY IN THE ARTERY. EVENTUALLY THE CLINICIAN REMOVED TO FIND THE WIRE BENT. CLINICIAN ATTEMPTED ANOTHER INSERTION WITH THE SAME ART LINE AND THE SAME THING OCCURRED. THE CLINICIAN THEN USED A PINK ANIO CATH WITH NO PROBLEMS." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ASSOCIATE MDR NUMBERS INCLUDE:9680794-2026-00214 AND 9680794-2026-00222.

    Description of Event or Problem · 0

    IT WAS REPORTED "AFTER INSERTION THE ART LINE AND USING THE WIRE, THE CANNULA WOULDN'T PUSH OFF THE NEEDLE/WIRE EVEN THOUGH CLEARLY IN THE ARTERY. EVENTUALLY THE CLINICIAN REMOVED TO FIND THE WIRE BENT. CLINICIAN ATTEMPTED ANOTHER INSERTION WITH THE SAME ART LINE AND THE SAME THING OCCURRED. THE CLINICIAN THEN USED A PINK ANIO CATH WITH NO PROBLEMS." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ASSOCIATE MDR NUMBERS INCLUDE:9680794-2026-00214 AND .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828880 ARROW RA CATH SET: 20 GA X 1-1/2 IN WIRE GUIDE CATHETER OFB ARROW INTERNATIONAL LLC UNKNOWN

    Patients

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