BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P15J

    MDR report key: 18959431 · Received March 22, 2024

    Report

    Report Number
    3003152976-2024-00187
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    March 15, 2024
    Report Date
    August 26, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    PMA / PMN Number
    K090634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: TWO PROTECTORS ATTACHED TO VIALS WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON THE PROTECTOR OR PROTECTOR MEMBRANE AND THE NEEDLE PROPERLY PENETRATED THE VIAL STOPPER ON ALL SAMPLES. FUNCTIONAL TESTING WAS COMPLETED, LIQUID INSIDE THE SYRINGE COULD MOVE TO THE VIAL AND BACK TO THE SYRINGE WITHOUT ISSUE AND NO LEAKS WERE OBSERVED. THE VIAL CAP WAS MEASURED ON ALL RETURNED PRODUCT, THE HEIGHT MEASURING 6.05MM AND 6.00 MM, WHICH IS BELOW THE STANDARD FOR THIS VIAL WHICH SHOULD BE 8MM. LEAKAGE TESTING IS PERFORMED FOR ALL LOTS DURING MANUFACTURING TO ENSURE THE QUALITY OF THE MEMBRANE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2212113, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PROTECTORS WERE SUCCESSFULLY CONNECTED TO THE VIALS, ENSURING THEY FIT PROPERLY. THE PRODUCT WAS EVALUATED AND NO DAMAGE OR DEFECTS WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, NO LEAK BETWEEN THE PROTECTOR AND VIAL WAS IDENTIFIED. BASED ON OUR INVESTIGATION, ALTHOUGH WE COULD NOT REPLICATE THE REPORTED FAILURE, IT WAS IDENTIFIED THAT THE VIAL SIZE WAS NOT COMPATIBLE WITH THE PROTECTOR USED WHICH CAN RESULT IN AN INSECURE CONNECTION BETWEEN THE PROTECTOR AND VIAL AND LEAD TO LEAKS SUCH AS THE ONE REPORTED. IT IS IMPORTANT CORRECT VIAL SIZE IS USED WITH THE PROTECTOR TO ENSURE A SECURE CONNECTION. THE M12 ASSEMBLY FIXTURE IS RECOMMENDED TO EASE THE CONNECTION OF THE PROTECTOR TO THE VIAL. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Description of Event or Problem · 0

    THIS IS A COMPLAINT ABOUT CHEMICAL LEAKAGE WHILE PREPARING ROSEUS USING P15J. ACCORDING TO THE CUSTOMER REPORT THE CHEMICAL SOLUTION LEAKED OUT WHEN COLLECTING IT. ASSEMBLY FIXTURE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554229 PROTECTOR P15J CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON 2212113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown