BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P15J

    MDR report key: 19971443 · Received August 13, 2024

    Report

    Report Number
    3003152976-2024-00458
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 22, 2024
    Report Date
    December 13, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: ONE PROTECTOR CONNECTED TO A VIAL WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A LEAK BETWEEN THE PROTECTOR AND VIAL WAS OBSERVED. UPON FURTHER EVALUATION, IT WAS NOTED THE PROTECTOR NEEDLE PENETRATED THE VIAL STOPPER OFF CENTER. THE PROTECTOR WAS RECONNECTED USING THE ASSEMBLY FIXTURE AND FUNCTIONAL TESTING WAS PERFORMED AGAIN, NO LEAKAGE OUTSIDE OF THE SYSTEM WAS OBSERVED. THE VIAL CAP WAS MEASURED ON THE RETURNED PRODUCT, THE HEIGHT MEASURING 5.80MM, WHICH IS BELOW THE STANDARD FOR THIS VIAL WHICH SHOULD BE 8MM. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2212114, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE PROTECTORS TO A VIAL, INJECTOR, AND SYRINGE PER THE INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT. ALL PROTECTORS WERE PROPERLY CONNECTED, LIQUID COULD MOVE THROUGH THE SYSTEM WITHOUT ISSUE AND NO LEAKAGES OCCURRED. BASED ON OUR INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. IT WAS IDENTIFIED THE PROTECTOR WAS NOT PROPERLY ATTACHED AND 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. THE M12 ASSEMBLY FIXTURE IS RECOMMENDED TO EASE THE CONNECTION OF THE PROTECTOR TO THE VIAL AND MUST BE USED IN A SLOW AND CONSISTENT MOTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEAKAGE OF DRUG SOLUTION WAS OBSERVED WHEN THE PROTECTOR 515121 WAS CONNECTED TO THE VIAL AND AN ATTEMPT WAS MADE TO COLLECT THE DRUG SOLUTION. IT IS UNCLEAR FROM WHICH PART OF THE VIAL LEAKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2485890 PROTECTOR P15J CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON 2212114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown