BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INJECTOR N35-O

    MDR report key: 14219964 · Received April 27, 2022

    Report

    Report Number
    3003152976-2022-00171
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    April 1, 2022
    Report Date
    July 5, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150524
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY NAME: (B)(6). 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: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 03-MAY-2022. H6: INVESTIGATION SUMMARY ONE SAMPLE UNIT WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON VISUAL INSPECTION OF THE SAMPLE, NO DEFECTS WERE OBSERVED. TESTING WAS PERFORMED AND FLUID WAS ABLE TO FLOW BETWEEN THE INJECTOR AND CONNECTOR WITHOUT ISSUE. THE INJECTOR WAS DISASSEMBLED FOR FURTHER EVALUATION, NO DAMAGE OR DEFECTS WITHIN ANY OF THE COMPONENTS WAS OBSERVED AND NO INDICATION OF AN OCCLUSION OR OTHER OBSTRUCTION WAS IDENTIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2111308, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL INSPECTIONS PRIOR TO RELEASE, INCLUDING VERIFICATION THE PRODUCT IS NOT DAMAGED, FLOW RATE, AND ALL CRITICAL DIMENSIONS MEET SPECIFICATIONS. UPON REVIEWING THE RESULTS FOR LOT 2111308, NO ISSUES WERE IDENTIFIED DURING TESTING AND THE PRODUCT MET THE REQUIRED CRITERIA FOR RELEASE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE SAMPLES WERE FUNCTIONALLY TESTED AND, IN ALL CASES, FLOW WAS OBSERVED AND THE PRODUCT FUNCTIONED AS INTENDED. BASED ON OUR INVESTIGATION AND SAMPLE EVALUATION, WE CANNOT IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD PHASEAL¿ OPTIMA INJECTOR N35-O, THERE WERE FLOW ISSUES WITH THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CHEMO WOULD NOT FLOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD PHASEAL¿ OPTIMA INJECTOR N35-O, THERE WERE FLOW ISSUES WITH THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CHEMO WOULD NOT FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096439 BD PHASEAL¿ OPTIMA INJECTOR N35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2111308 00382905150524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown