BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJ. OPTIV DH,SI W/OEM

    MDR report key: 20879973 · Received December 9, 2024

    Report

    Report Number
    1518293-2024-00022
    Event Type
    Injury
    Date Received
    December 9, 2024
    Date of Event
    November 12, 2024
    Report Date
    December 9, 2024
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    UDI-DI
    10746190002710
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON OPTIVANTAGE INJECTOR 844005 SERIAL NUMBER (B)(6) ALLEGING THAT THERE WAS A PRESENCE OF AIR BUBBLES WHEN READING IMAGES. THERE WERE NO ADVERSE IMPACTS FOR ANY OF THE PATIENTS RELATED TO THIS COMPLAINT. PER CUSTOMER REQUEST, GUERBET SERVICE WAS DISPATCHED TO THE SITE AND EVALUATED THE INJECTOR. SERVICE FOUND NO ALARMS NOR ANY OTHER ISSUE DURING THE EVALUATION. THE INJECTOR WAS FULLY FUNCTIONAL AND COMPLIANT. GUERBET'S COMPLAINT TRACKING SYSTEM WAS REVIEWED AND SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY: NO INJURY TO THE PATIENT/USER REPORTED IMDRF CODES: B01, C23, C19, D11, D14. ROOT / PROBABLE CAUSE CODE. PROCESS/METHODS - INADEQUATE/INCORRECT PROCEDURE. ROOT / PROBABLE CAUSE SUMMARY: REFER TO INVESTIGATION SUMMARY. NO ADDITIONAL CAPA REQUIRED AT THIS TIME. GUERBET QUALITY WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. THESE TRENDS AND ISSUES ARE REPORTED ON DURING QUALITY METRICS REVIEW AND DURING THE MANAGEMENT REVIEWS TO CONSIDER INPUT FOR ADDITIONAL CORRECTIVE ACTION. DISPOSITION SUMMARY: UNIT RETURNED TO CUSTOMER USE.

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN FRANCE ON (B)(6) 2024. CUSTOMER STATES THAT THERE WAS THE PRESENCE OF AIR BUBBLES WHEN READING IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337667 INJ. OPTIV DH,SI W/OEM INJ. OPTIV DH,SI W/OEM IZQ LIEBEL-FLARSHEIM 844005 10746190002710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown