BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35J

    MDR report key: 15677227 · Received October 26, 2022

    Report

    Report Number
    3003152976-2022-00478
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    October 3, 2022
    Report Date
    January 5, 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

    H6: INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2110010, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS WERE OBSERVED. LEAKAGE TESTING WAS PERFORMED AND IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKAGES OCCURRED. THE INJECTORS WERE DISASSEMBLED FOR FURTHER INSPECTION. THE PRODUCTS WERE VERIFIED TO BE PROPERLY ASSEMBLED AND NO ISSUES WERE FOUND WITHIN THE DEVICE THAT COULD HAVE LEAD TO ANY LEAK. BASED ON THE AVAILABLE INFORMATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    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¿ INJECTOR LUER LOCK N35J EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: LIQUID MEDICINE LEAKED FROM BETWEEN THE CYLINDER AND THE NEEDLE STORAGE CYLINDER. THERE WAS A WOBBLE IN THE CYLINDER PART.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK N35J EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: LIQUID MEDICINE LEAKED FROM BETWEEN THE CYLINDER AND THE NEEDLE STORAGE CYLINDER. THERE WAS A WOBBLE IN THE CYLINDER PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510590 BD PHASEAL¿ INJECTOR LUER LOCK N35J INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2110010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown