BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U401SX

    MDR report key: 17452226 · Received August 3, 2023

    Report

    Report Number
    2429304-2023-00251
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    July 12, 2023
    Report Date
    July 1, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170388248
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    THE INCIDENT OCCURRED DURING A FINE NEEDLE ASPIRATION (FNA) OF THE PATIENT¿S SUBCARINAL LYMPH NODE AND LEFT HILAR MASS. THE TOTAL DURATION OF THE PROCEDURE WAS 65 MINUTES. IT WAS REPORTED THAT THE PROCEDURE WAS PROLONGED DUE TO THE NEED TO OPEN ANOTHER NEEDLE. HOWEVER, THE EXACT TIME IT TOOK TO OPEN THE NEW DEVICE WAS UNSPECIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A DIAGNOSTIC PROCEDURE, SPECIMEN RETRIEVAL, THE CATHETER SHEATH FELL APART, SHREDDED OR PIECES CAME OFF. NOTHING WAS LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS PROLONGED FOR SIXTY-FIVE MINUTES TO OPEN A NEW DEVICE AND COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUPPLEMENTED TO UPDATE TO THE CORRECT DEVICE LOT NUMBER (K114558) IN D4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281071 SINGLE USE ASPIRATION NEEDLE NA-U401SX SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-U401SX-4021 K114558 04953170388248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention