BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW EXT DWELL CATH DEVICE

    MDR report key: 14578000 · Received June 2, 2022

    Report

    Report Number
    9680794-2022-00357
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 16, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#: (B)(4). THE MDR REPORT KEY IS (B)(4). THE MDR TEXT KEY IS (B)(4). THE REPORT NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE MDR REPORT KEY IS 14188122. THE MDR TEXT KEY IS 289978535. THE REPORT NUMBER IS MW5109276. 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. CORRECTED DATA: SECTION E.4. CORRECTED TO 'YES'.

    Description of Event or Problem · 0

    COMPLAINT FOUND IN MAUDE DATABASE REPORTS: "A 20GA ENDURANCE CATHETER INSERTED ON (B)(6) 2022. WHEN THE CATHETER WAS DISCONTINUED ON (B)(6) 2022 APPROX 5CM OF THE CATHETER TIP WAS RETAINED. SURGICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE RETAINED CATHETER."

    Description of Event or Problem · 0

    COMPLAINT FOUND IN MAUDE DATABASE REPORTS: "A 20GA ENDURANCE CATHETER INSERTED ON (B)(6) 2022. WHEN THE CATHETER WAS DISCONTINUED ON (B)(6) 2022 APPROX 5CM OF THE CATHETER TIP WAS RETAINED. SURGICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE RETAINED CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161428 ARROW EXT DWELL CATH DEVICE CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention