BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW RA CATH SET: 20 GA X 1-3/4"

    MDR report key: 14577753 · Received June 2, 2022

    Report

    Report Number
    9680794-2022-00356
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    April 4, 2022
    Report Date
    May 16, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQX
    UDI-DI
    00801902002730
    PMA / PMN Number
    K810675
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 14104496. THE MDR TEXT KEY IS 289273494. THE REPORT NUMBER IS MW5108942. 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.

    Description of Event or Problem · 0

    COMPLAINT FROM MAUDE DATABASE REPORTS: "A (B)(6) UNDERWENT L1-2 FORAMINOTOMY, DISC DEBRIDEMENT, WASHOUT OF EPIDURAL ABSCESS AND DISCITIS. MD ATTEMPTED TO PUT IN ARTERIAL LINE ON RIGHT ARM AT THE BEGINNING OF THE CASE; WHEN MD REMOVED THE CATHETER, ONLY HUB AND PART OF THE CATHETER CAME OUT WITH THE REST DISLODGED IN THE PATIENTS. UNABLE TO RETRIEVE THE MISSING PIECE. PATIENT UNDERWENT EMERGENT BRACHIAL ARTERY EXPLORATION AND REMOVAL OF CATHETER RIGHT ARM. CATHETER WAS CONTAINED IN THE SUBCUTANEOUS TISSUE BENEATH THE DERMIS. CATHETER WAS REMOVED IN ITS ENTIRETY."

    Description of Event or Problem · 0

    COMPLAINT FROM MAUDE DATABASE REPORTS: "A (B)(6) UNDERWENT L1-2 FORAMINOTOMY, DISC DEBRIDEMENT, WASHOUT OF EPIDURAL ABSCESS AND DISCITIS. MD ATTEMPTED TO PUT IN ARTERIAL LINE ON RIGHT ARM AT THE BEGINNING OF THE CASE; WHEN MD REMOVED THE CATHETER, ONLY HUB AND PART OF THE CATHETER CAME OUT WITH THE REST DISLODGED IN THE PATIENTS. UNABLE TO RETRIEVE THE MISSING PIECE. PATIENT UNDERWENT EMERGENT BRACHIAL ARTERY EXPLORATION AND REMOVAL OF CATHETER RIGHT ARM. CATHETER WAS CONTAINED IN THE SUBCUTANEOUS TISSUE BENEATH THE DERMIS. CATHETER WAS REMOVED IN ITS ENTIRETY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227731 ARROW RA CATH SET: 20 GA X 1-3/4" WIRE GUIDE CATHETER DQX ARROW INTERNATIONAL LLC IPN035912 00801902002730

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention