BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJ, OPTIV, MULI

    MDR report key: 24097012 · Received January 16, 2026

    Report

    Report Number
    1518293-2025-00020
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    December 10, 2025
    Report Date
    January 16, 2026
    Manufacturer
    LIEBEL- FLARSHEIM
    Product Code
    IZQ
    UDI-DI
    10746190002833
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: REGIONAL SERVICE REPORTED SHIPPING TO CUSTOMER A REPLACEMENT 200 ML FACEPLATE ASSEMBLY PN: 844862 TO REPLACE THE FACEPLATE THEY REPORTED HAD A BROKEN PRESSURE SLEEVE PN: 800367. THE WAS NO OTHER ISSUE REPORTED WITH THE INJECTOR. A REVIEW OF CTS SHOWS NO SIMILAR ISSUE REPORTED ON THIS UNIT. IMPACT ASSESSMENT SUMMARY: NO INJURY TO THE PATIENT/USER REPORTED IMDRF CODES: B01; C07; D15. ROOT/PROBABLE CAUSE CODE. UNKNOWN. 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 REMAINED IN SERVICE.

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) NETHERLANDS ON 11 DECEMBER 2025. CUSTOMER REPORTED THAT INJECTOR HEAD BROKE DURING THE AUTOMATIC VENTING PROCESS. THE COLLEAGUE STARTED THE PROCEDURE ON THE PUMP, AND THEN THE SYRINGE BEGAN TO LEAK. THAT'S WHEN SHE DISCOVERED THAT THE INJECTOR HEAD HAD BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165550 INJ, OPTIV, MULI INJ, OPTIV, MULI IZQ LIEBEL- FLARSHEIM 844008 10746190002833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death