BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW EXT DWELL CATH DEVICE 20GAX8CM

    MDR report key: 14312592 · Received May 6, 2022

    Report

    Report Number
    9680794-2022-00272
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    March 9, 2022
    Report Date
    April 13, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    10801902132960
    PMA / PMN Number
    K151513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE MDR REPORT KEY IS (B)(4). THE MDR TEXT KEY IS (B)(4). THE REPORT NUMBER IS MW5108215.

    Additional Manufacturer Narrative · 0

    (B)(4). THE MDR REPORT KEY IS (B)(4). THE MDR TEXT KEY IS (B)(4). THE REPORT NUMBER IS MW5108215. 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

    COMPLAINT FOUND IN MAUDE DATABASE REPORTS: "PICC LINE PLACEMENT ATTEMPT RESULTED IN CATHETER THAT WOULD NOT THREAD AND UPON REMOVAL NOTED THE TIP OF CATHETER LOOKED TORN. US AND DOPPLER CONFIRMED CATHETER FRAGMENT IN CEPHALIC VEIN. LINEAR ECHOGENIC STRUCTURE IN THE LEFT CENTRAL UPPER ARM IN THE CEPHALIC VEIN IS CONSISTENT WITH A SMALL PIECE OF RETAINED CATHETER FRAGMENT. VASCULAR CONSULTED."

    Description of Event or Problem · 0

    COMPLAINT FOUND IN MAUDE DATABASE REPORTS: "PICC LINE PLACEMENT ATTEMPT RESULTED IN CATHETER THAT WOULD NOT THREAD AND UPON REMOVAL NOTED THE TIP OF CATHETER LOOKED TORN. US AND DOPPLER CONFIRMED CATHETER FRAGMENT IN CEPHALIC VEIN. LINEAR ECHOGENIC STRUCTURE IN THE LEFT CENTRAL UPPER ARM IN THE CEPHALIC VEIN IS CONSISTENT WITH A SMALL PIECE OF RETAINED CATHETER FRAGMENT. VASCULAR CONSULTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079368 ARROW EXT DWELL CATH DEVICE 20GAX8CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC IPN037862 14F21M0014 10801902132960

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other