BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 16395161 · Received February 17, 2023

    Report

    Report Number
    3005975494-2023-00024
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    November 9, 2022
    Report Date
    June 14, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    KTI
    UDI-DI
    00821925043060
    PMA / PMN Number
    K163469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS TO INFORM THAT UPON FURTHER REVIEW, THIS EVENT HAS ALREADY BEEN REPORTED ON MEDWATCH 3005975494-2022-00071 (PATIENT IDENTIFIER (B)(6)). REFER TO THIS FILE FOR SUPPLEMENTAL INFORMATION RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE IS UNKNOWN AT THIS TIME. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED, DURING ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) PORTION OF PROCEDURE (DIAGNOSTIC) AFTER COLLECTING SAMPLE, THE NEEDLE WAS STUCK INSIDE THE SHEATH. STAFF COULD NOT REMOVE NEEDLE FROM THE SHEATH TO OBTAIN ANY FURTHER SAMPLES. NEW NEEDLE WAS OPENED. PER THE CUSTOMER, DEVICE WAS EXAMINED. NO HOLES NOTED ON OUTSIDE OF PLASTIC SHEATH THAT COULD BE IDENTIFIED. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED. THE REPORTED ISSUE OCCURRED ON THE SAME MODEL (NA-U403SX-4019) WITH DIFFERENT LOT NUMBERS ON DIFFERENT EVENT DATE. THIS EVENT INCLUDES FOUR (4 ) REPORTS TO CAPTURE THE REPORTED ISSUE OCCURRED ON THE SAME MODEL WITH DIFFERENT LOT NUMBERS AND EVENT DATE. REPORT WITH PATIENT IDENTIFIER (B)(6) (LOT KR151147) - EVENT DATE OF (B)(6) 2022. REPORT WITH PATIENT IDENTIFIER (B)(6) (UNKNOWN LOT) -DISPOSED BY THE CUSTOMER- NOT SAVED- EVENT DATE OF (B)(6) 2022. REPORT WITH PATIENT IDENTIFIER (B)(6) (LOT KR232986) - EVENT DATE OF (B)(6) 2022. REPORT WITH PATIENT IDENTIFIER (B)(6) (LOT KR232986) -UNKNOWN EVENT DATE. THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (LOT KR232986) - EVENT DATE OF (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116100 SINGLE USE ASPIRATION NEEDLE VIZISHOT 2 FLEX KTI GYRUS ACMI, INC. NA-U403SX-4019 KR232986 00821925043060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown