BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INFUSION CONNECTOR C35-O

    MDR report key: 13716038 · Received March 9, 2022

    Report

    Report Number
    3003152976-2022-00096
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    February 24, 2022
    Report Date
    April 22, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150708
    PMA / PMN Number
    K201099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    H6: INVESTIGATION SUMMARY NO PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE PROVIDED FOR INVESTIGATION. ONE PHOTO OF THE INJECTOR WAS RECEIVED. THROUGH VISUAL INSPECTION, THE CONNECTOR IS OBSERVED TO BE DISCONNECTED FROM THE TUBING. THERE IS NO VISIBLE DAMAGE TO THE CONNECTOR. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2110512, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. ONE ANNOTATION WAS NOTED DURING THE MOLDING PROCESS FOR THE CONNECTOR BODY. IT WAS IDENTIFIED THAT THE CAVITY WAS NOT COMPLETELY FILLED WHEN FORMING THE PIECE. THE ISSUE WAS SOLVED IN PROCESS, ALL PRODUCT UNDERWENT INSPECTIONS, AND RECORDS VERIFY PROPER PROCESS WAS FOLLOWED TO SOLVE THE ISSUE AND SEGREGATE IMPACTED PRODUCT. GIVEN WE DO NOT HAVE A PHYSICAL SAMPLE TO EVALUATE, WE CANNOT CONFIRM THIS IS RELATED TO ANY ISSUES WITH THE LUER. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. DIMENSIONAL TESTING WAS PERFORMED, INCLUDING THE LUER THREAD, VERIFYING ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. PRODUCT UNDERGOES A SERIES OF VISUAL AND FUNCTIONAL EVALUATIONS THROUGHOUT THE MANUFACTURING PROCESS. RECORDS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES RELATED TO THIS FAILURE WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ OPTIMA INFUSION CONNECTOR C35-O A THE CONNECTOR DISCONNECTED FROM THE TUBING AND LEAKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED LEAKAGE FROM TUBING DISCONNECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ OPTIMA INFUSION CONNECTOR C35-O A THE CONNECTOR DISCONNECTED FROM THE TUBING AND LEAKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED LEAKAGE FROM TUBING DISCONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539165 BD PHASEAL¿ OPTIMA INFUSION CONNECTOR C35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2110512 00382905150708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown