BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P14J

    MDR report key: 17740549 · Received September 13, 2023

    Report

    Report Number
    3003152976-2023-00385
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 28, 2023
    Report Date
    October 22, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FOUR SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. FUNCTIONAL TESTING WAS PERFORMED ON THE SAMPLES, NO LEAK BETWEEN THE PROTECTOR AND VIAL WAS IDENTIFIED. ADDITIONAL EVALUATIONS WERE COMPLETED, ATTACHING THE PROTECTORS TO AN EMPTY VIAL AND INSERTING LIQUID. IN ALL CASES, THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKAGE WAS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2210139, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING LEAKAGE TESTING. TESTING RESULTS WERE REVIEWED FOR LOT 2210139 AND NO ISSUES WERE IDENTIFIED, PRODUCT WAS VERIFIED TO MEET REQUIRED SPECIFICATIONS. BASED ON THE INVESTIGATION RESULTS AND SAMPLE EVALUATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO THE DEVICE OR OUR MANUFACTURING PROCESS AT THIS TIME. IT IS POSSIBLE THE PROTECTOR WAS NOT PROPERLY CONNECTED TO THE VIAL WHICH RESULTED IN THE LEAK REPORTED. THE PROTECTOR MUST BE ATTACHED COMPLETELY VERTICAL . 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14J EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS REPORT IS ABOUT LEAKAGE AFTER VIAL ATTACHMENT. A PROTECTOR WAS ATTACHED TO THE KEYTRUDA FOR ALL FOUR VIALS. A SLIGHT SPLASH AND WETTING OF THE SHEET WERE OBSERVED DURING PREPARATION. IT WAS MOST LIKELY LEAKED FROM ONE OF THE VIALS. AN INVESTIGATION INTO THE CAUSE HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14J EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS REPORT IS ABOUT LEAKAGE AFTER VIAL ATTACHMENT. A PROTECTOR WAS ATTACHED TO THE KEYTRUDA FOR ALL FOUR VIALS. A SLIGHT SPLASH AND WETTING OF THE SHEET WERE OBSERVED DURING PREPARATION. IT WAS MOST LIKELY LEAKED FROM ONE OF THE VIALS. AN INVESTIGATION INTO THE CAUSE HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061174 BD PHASEAL¿ PROTECTOR P14J INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2210139

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown