BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL INJECTOR LUER LOCK

    MDR report key: 15160739 · Received August 3, 2022

    Report

    Report Number
    3003152976-2022-00343
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    June 30, 2022
    Report Date
    November 7, 2022
    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

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?: YES. D10: RETURNED TO MANUFACTURER ON: 07-NOV-2022 H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE WAS OBSERVED ON THE INJECTOR OR LUER THREADING OF THE INJECTOR. UPON OUR INITIAL EVALUATION, A LEAK BETWEEN THE INJECTOR AND SYRINGE WAS OBSERVED, HOWEVER, IT WAS NOTED THE LUER CONNECTION WAS NOT SECURE. AFTER PROPERLY TIGHTENING THE LUER CONNECTIONS, FUNCTIONAL TESTING WAS PERFORMED AND NO ADDITIONAL LEAKAGE OCCURRED. 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 THESE ISSUES. PRODUCT UNDERGOES A SERIES OF TESTING AND INSPECTIONS THROUGHOUT MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING LEAKAGE TESTING AND VERIFICATION THAT ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. FIVE RETAINED SAMPLES OF LOT 2110010 WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS WERE OBSERVED, ALL LUER CONNECTIONS WERE SECURE, AND NO LEAKAGES OCCURRED. BASED ON THE AVAILABLE INFORMATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED BD PHASEAL INJECTOR LUER LOCK HAD LEAKAGE BETWEEN THE INJECTOR AND THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT LEAKAGE OF AN ANTICANCER AGENT FROM THE CONNECTION BETWEEN THE INJECTOR AND SYRINGE. FLUID LEAKED FROM AROUND THE CONNECTION BETWEEN THE INJECTOR AND THE SYRINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED BD PHASEAL INJECTOR LUER LOCK HAD LEAKAGE BETWEEN THE INJECTOR AND THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT LEAKAGE OF AN ANTICANCER AGENT FROM THE CONNECTION BETWEEN THE INJECTOR AND SYRINGE. FLUID LEAKED FROM AROUND THE CONNECTION BETWEEN THE INJECTOR AND THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162233 BD PHASEAL INJECTOR LUER LOCK INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2110010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown