BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 17137746 · Received June 15, 2023

    Report

    Report Number
    9614641-2023-00851
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    March 23, 2023
    Report Date
    June 15, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170389887
    PMA / PMN Number
    K050503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION FOUND ALL SEVEN SYRINGES WERE EXPIRED. THE SUBJECT DEVICE WAS MANUFACTURED IN NOVEMBER 2020 BASED ON THE PROVIDED THREE DIGIT LOT INFORMATION "0YV", BUT THE SPECIFIC DATE IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "DO NOT USE THE EXPIRED ASPIRATION NEEDLES, DISPOSABLE ADAPTER FORCEPS PLUGS, OR MEDALLION SYRINGES LISTED ON THE STERILE PACK. IT MAY LEAD TO INFECTION, TISSUE INFLAMMATION, ETC". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THAT SEVEN PACKAGES OF SINGLE USE ASPIRATION NEEDLES ARRIVED EXPIRED. THE ISSUE WAS FOUND DURING RECEIPT INSPECTION. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE UNKNOWN POTENTIAL FOR RISK OF HARM DUE TO THE MALFUNCTION, AS DESCRIBED IN THE RISK SUMMARY APPLICATION (RSA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2093398 SINGLE USE ASPIRATION NEEDLE SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-201SX-4022 0YV 04953170389887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown