BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21967520 · Received May 6, 2025

    Report

    Report Number
    9680794-2025-00375
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    February 22, 2025
    Report Date
    April 14, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQX
    UDI-DI
    00801902002761
    PMA / PMN Number
    K810675
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN #: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE COMPLAINT OF CATHETER SEPARATED DURING USE CANNOT BE CONFIRMED BY THE PHOTO AS IT ONLY REVEALS THE LIDSTOCK OF THE PRODUCT. NO VISUAL EVIDENCE OF THE CATHETER SEPARATION WAS PROVIDED. ADDITIONALLY, A COMPLETE VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "WARNING: DO NOT USE EXCESSIVE FORCE IN REMOVING CATHETER. IF RESISTANCE IS MET ON REMOVAL, STOP AND FOLLOW INSTITUTIONAL POLICIES AND PROCEDURES FOR DIFFICULT TO REMOVE CATHETERS." WITHOUT THE DEVICE TO EVALUATE, 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, "TIP BROKE OFF IN PATIENT ARTERY. PATIENT HAD ARTERIAL LINE INSERTED IN ED, FOLLOWING THE PATIENT PROCEDURES, PACU NURSE REMOVED ARTERIAL LINE FROM PATIENT, TIP OF THE ARTERIAL CANNULA WAS MISSING AND LEFT IN THE PATIENT'S RADIAL ARTERY. VASCULAR MEDICAL TEAM WAS CONSULTED AND REPORTED NO NEED TO RETRIEVE TIP OF ARTERIAL CANNULA FROM PATIENT RADIAL ARTERY. PACU NURSE INFORMED TREATING ANAESTHETIST, NEUROVASCULAR OBSERVATIONS AND ONGOING MONITORING OF THE PATIENT. ULTRASOUND WAS USED TO DETERMINE IF TIP PRESENT IN ARTERY (WAS CONFIRMED), ANAESTHETIST CONTACTED GEN SURGICAL AND VASCULAR TEAM FOR CONSULT. NO FURTHER INTERVENTION/EXPLORATION. PATIENT CONTINUED TO MONITOR NVO OVERNIGHT." 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 "TIP BROKE OFF IN PATIENT ARTERY. PATIENT HAD ARTERIAL LINE INSERTED IN ED, FOLLOWING THE PATIENT PROCEDURES, PACU NURSE REMOVED ARTERIAL LINE FROM PATIENT, TIP OF THE ARTERIAL CANNULA WAS MISSING AND LEFT IN THE PATIENT'S RADIAL ARTERY. VASCULAR MEDICAL TEAM WAS CONSULTED AND REPORTED NO NEED TO RETRIEVE TIP OF ARTERIAL CANNULA FROM PATIENT RADIAL ARTERY. PACU NURSE INFORMED TREATING ANAESTHETIST, NEUROVASCULAR OBSERVATIONS AND ONGOING MONITORING OF THE PATIENT. ULTRASOUND WAS USED TO DETERMINE IF TIP PRESENT IN ARTERY (WAS CONFIRMED), ANAESTHETIST CONTACTED GEN SURGICAL AND VASCULAR TEAM FOR CONSULT. NO FURTHER INTERVENTION/EXPLORATION. PATIENT CONTINUED TO MONITOR NVO OVERNIGHT." 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
    1895505 ARROW RA CATH SET: 20 GA X 1-1/2 IN WIRE GUIDE CATHETER DQX ARROW INTERNATIONAL LLC 14F24E0085 00801902002761

    Patients

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