BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    44 CM (17") PUR EXT SET W/CLAVE® SPIKE, 0.2 ¿M FILTER AND BCV MLL

    MDR report key: 22372196 · Received July 1, 2025

    Report

    Report Number
    9617594-2025-01404
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    June 4, 2025
    Report Date
    September 25, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619032661
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, HAS NOT YET BEEN RECEIVED. D10: DOSTARLIMAB (LOT: L243168; EXP: 05/2027, KIT: 204619) IN NACL 0.9% 100 ML INFUSION (LOT 25D24G61 EXP 3/2027).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION B5.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY. THE COMPLAINT OF PARTICULATE MATTER ON ITEM 011-H2862 CANNOT BE CONFIRMED. SINCE NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND PROBABLE CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY WAS REVIEWED, AND NO NON-CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED CONDITION ON THE COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 44 CM (17") PUR EXT SET W/CLAVE® SPIKE, 0.2 M FILTER AND BCV MLL WHERE IT WAS REPORTED THERE WERE PARTICLES IN AN INFUSION BAG USING DOSTARLIMAB IN A CLINICAL STUDY. THE PREPARED INFUSION CONTAINED MANY SMALL WHITE PARTICLES. A REPORT WAS MADE FOR THE PRODUCT DOSTARLIMAB, BUT THIS TIME IT CONCERNED A DIFFERENT STUDY (AZUR-2, PROTOCOL 219606, SPONSOR GLAXOSMITHKLINE PHARMACEUTICALS). INFUSION WAS PREPARED A SECOND TIME WITH NEW DOSTARLIMAB VIALS BUT WITHOUT THE USE OF CHEMOCLAVE, I.E. WITH SYRINGE AND NEEDLE AND NO PARTICLES WERE OBSERVED. THE PHARMACY MANUAL OF THIS STUDY STATES THAT THIS PRODUCT MAY BE PREPARED WITH CHEMOCLAVE, SO IT WAS ASSUMED THAT COMPATIBILITY TESTS HAVE ALREADY BEEN PERFORMED. THE PROBLEM OCCURRED DURING RECONSTITUTION OF THE IMP. PARTICLES WERE FORMED UPON TIME OF DILUTION OF THE CONCENTRATED IMP PEMBROLIZUMAB INTO THE SALINE INFUSION BAG. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. PATIENT WAS NOT HARMED, ONLY DELAY OF THERAPY AND INFUSION BAG WITH PARTICLES WAS NOT DISPENSED NOR ADMINISTERED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PRODUCT WAS STORED IN A DRY PLACE, AT ROOM TEMPERATURE. NO CUTS, HOLES, DEFECTS WERE VISIBLE ON THE PRODUCT. THE PACKAGING AND THE PRODUCT ITSELF WERE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244960 44 CM (17") PUR EXT SET W/CLAVE® SPIKE, 0.2 ¿M FILTER AND BCV MLL STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14253745 00840619032661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DOSTARLIMAB IN NACL 0.9% 100 ML INFUSION, UNK MFR.