BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL

    MDR report key: 23616960 · Received November 21, 2025

    Report

    Report Number
    3003152976-2025-00645
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 8, 2025
    Report Date
    December 2, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905151026
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR, IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: IT WAS REPORTED THAT BLACK PARTICLES WERE OBSERVED WITHIN THE VIAL AFTER USE OF OUR PRODUCT. TWO PHOTOS AND TEN UNUSED SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE FIRST PHOTO SHOWS THE PROTECTOR WITHOUT ANY VISIBLE DAMAGE OR RELATED DEFECT, WHILE THE SECOND PHOTO SHOWS THE VIAL WITH A PARTICLE AT THE BOTTOM, CONFIRMING THE REPORTED CONCERN. FRAGMENTATION TESTING IS ROUTINELY PERFORMED DURING MANUFACTURING TO EVALUATE PARTICULATE GENERATION AFTER TEN ACTIVATIONS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR PROTECTOR LOT 2501102, AND NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONCERN. THE RESULTS FOR THE REPORTED LOTS WERE REVIEWED AND FOUND TO BE WITHIN SPECIFICATION. FRAGMENTATION TESTING WAS CONDUCTED ON THE RETURNED PRODUCTS AND VERIFIED THE PRODUCT MET REQUIRED SPECIFICATION. WHILE PHASEAL NEEDLES ARE DESIGNED TO REDUCE CORING (FRAGMENTATION), THERE ARE SEVERAL FACTORS THAT MAY IMPACT CORING TENDENCY. CORING OF THE RUBBER STOPPER MAY RESULT DEPENDING ON THE STOPPER QUALITY, THE DESIGN AND DIMENSIONS OF THE NEEDLES USED, OR IF A POOR CONNECTION OF THE PROTECTOR OCCURS. IT IS IMPORTANT TO ENSURE THE VIAL IS NOT EXPIRED AS THAT CAN IMPACT THE QUALITY OF THE RUBBER STOPPER. IT IS POSSIBLE THAT THE PARTICLE WAS GENERATED DURING ASSEMBLY OF THE PROTECTOR ONTO THE VIAL; HOWEVER, WITHOUT THE PHYSICAL SAMPLE FOR FURTHER EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 0

    EVENT DETAILS: IN THE CLINICAL TRIALS CARRIED OUT IN OUR COMPANY, THE BD PHASEAL¿ PROTECTOR P21 DEVICE, WHICH IS A PRODUCT OF YOUR COMPANY, IS USED. IN A CLINICAL RESEARCH CENTER, DURING THE DRUG PREPARATION PROCESS, THERE WERE NO VISIBLE PARTICLES IN THE LYOPHILIZED POWDER OR THE STERILE SOLUTION USED, WHILE BLACK PARTICLES WERE OBSERVED IN THE LIQUID MIXTURE AFTER MIXING THE POWDER AND SOLUTION USING THE BD PHASEAL¿ PROTECTOR P21 DEVICE. THIS SITUATION WAS REPEATED IN 6-7 DIFFERENT VIALS. WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN WE DID NOT ADMINISTER DAMAGED RESEARCH PRODUCTS TO THE PATIENT. THEREFORE, OUR PATIENTS WERE NOT HARMED. WHAT MEDICATION VIALS IS THIS OCCURRING WITH? MK-3120 LYOPHILIZED POWDER FOR INFUSION 100 MG/VIAL: MK-3120 LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION IS A STERILE, NON-PYROGENIC POWDER SUPPLIED IN A SINGLE-USE TYPE I GLASS VIAL CONTAINING 100 MG/5 ML (20 MG/ML) OF MK-3120. THE PRODUCT IS A PRESERVATIVE-FREE, LATEX FREE SOLUTION WHICH IS ESSENTIALLY FREE OF EXTRANEOUS PARTICULATES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346753 BD PHASEAL PROTECTOR (P21) ONB BECTON DICKINSON, S.A. 2501102 00382905151026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown