BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR LUER LOCK C45J

    MDR report key: 8996406 · Received September 11, 2019

    Report

    Report Number
    3003152976-2019-00620
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 21, 2019
    Report Date
    November 14, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PRODUCT, NO DEFECTS WERE IDENTIFIED. A FLOW TEST WAS PERFORMED USING THE SAMPLE C45 CONNECTOR WITH A SYRINGE AND N35 INJECTOR, NO OCCLUSIONS OR FLOW ISSUES WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF BATCH 1810107. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. TESTING WAS REVIEWED FOR THE REPORTED LOT AND ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FLOWS ISSUES OCCURRED BEFORE USE WITH A CONNECTOR LUER LOCK C45J. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DRUG DIDN'T FLOW. AFTER REPLACED BY NEW PRODUCT, THE ISSUE WAS RESOLVED."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT FLOWS ISSUES OCCURRED BEFORE USE WITH A CONNECTOR LUER LOCK C45J. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DRUG DIDN'T FLOW. AFTER REPLACED BY NEW PRODUCT, THE ISSUE WAS RESOLVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794522 CONNECTOR LUER LOCK C45J CONNECTOR LHI BECTON DICKINSON, S.A. 1810107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other