BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24775615 · Received April 3, 2026

    Report

    Report Number
    9680794-2026-00239
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 9, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    OFB
    UDI-DI
    00801902002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    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. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "ON (B)(6) 2026, DURING ARTERIAL CANNULATION ON A PATIENT, AFTER SUCCESSFUL PUNCTURE, WHEN CONNECTING THE CATHETER TO THE TRANSDUCER, IT WAS FOUND THAT THE CONNECTION COULD NOT BE FULLY TIGHTENED AND SEALED, RESULTING IN CONTINUOUS BLOOD LEAKAGE. THIS CAUSED THE INVASIVE BLOOD PRESSURE MONITORING TO FAIL. AFTER IMMEDIATELY REPLACING WITH A NEW ARTERIAL CATHETER KIT, THE CONNECTION WAS TIGHT AND BLOOD PRESSURE MONITORING RETURNED TO NORMAL". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "(B)(6) 2026, DURING ARTERIAL CANNULATION ON A PATIENT, AFTER SUCCESSFUL PUNCTURE, WHEN CONNECTING THE CATHETER TO THE TRANSDUCER, IT WAS FOUND THAT THE CONNECTION COULD NOT BE FULLY TIGHTENED AND SEALED, RESULTING IN CONTINUOUS BLOOD LEAKAGE. THIS CAUSED THE INVASIVE BLOOD PRESSURE MONITORING TO FAIL. AFTER IMMEDIATELY REPLACING WITH A NEW ARTERIAL CATHETER KIT, THE CONNECTION WAS TIGHT AND BLOOD PRESSURE MONITORING RETURNED TO NORMAL" THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289790 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 NA Unknown NOT REPORTED.| NOT REPORTED.