BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR LUER LOCK N35C MULTIPACK

    MDR report key: 11467429 · Received March 11, 2021

    Report

    Report Number
    3003152976-2021-00135
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 12, 2021
    Report Date
    July 1, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K140591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/27/2021. H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED FOR EVALUATION. UPON INSPECTION OF THE PRODUCT, NO DAMAGE OR OTHER DEFECTS WERE OBSERVED THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND NO LEAKAGE WAS OBSERVED. FIVE RETAINED INJECTOR SAMPLES OF LOT 2001108 WERE USED FOR ADDITIONAL EVALUATION. FUNCTIONAL TESTING WAS PERFORMED, NO LEAKAGES FROM THE LUER CONNECTION OR INJECTOR MEMBRANE OCCURRED DURING TESTING THAT WAS PERFORMED. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL EVALUATIONS THROUGHOUT MANUFACTURING, INCLUDING LEAKAGE TESTING TO ENSURE THE QUALITY OF THE MEMBRANE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2001108 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE SAMPLE EVALUATION AND OUR QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE INJECTOR OR OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INJECTOR LUER LOCK N35C MULTIPACK EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT LEAKAGE FROM THE INJECTOR. ACCORDING TO THE CUSTOMER'S REPORT, LEAKAGE WAS FOUND DURING INFUSION OF THE THIRD AGENT (PACLITAXEL).

    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 THE INJECTOR LUER LOCK N35C MULTIPACK EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT LEAKAGE FROM THE INJECTOR. ACCORDING TO THE CUSTOMER'S REPORT, LEAKAGE WAS FOUND DURING INFUSION OF THE THIRD AGENT (PACLITAXEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359270 INJECTOR LUER LOCK N35C MULTIPACK INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2001108

    Patients

    Seq Age Sex Outcome Treatment
    1