BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N40-O)

    MDR report key: 12327614 · Received August 16, 2021

    Report

    Report Number
    3003152976-2021-00478
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    July 19, 2021
    Report Date
    October 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150562
    PMA / PMN Number
    K201099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: (B)(6) 2021. INVESTIGATION SUMMARY THREE SAMPLES RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION NO ANOMALIES OR DAMAGES WERE OBSERVED ON THE N-HUB (LUER PART) FROM OPTIMA INJECTOR N40-0. ALL SAMPLES RECEIVED WERE DISASSEMBLED AND THE N-HUB PART FROM ALL RETURNED SAMPLES WAS MEASURED, ALL SAMPLES MET ACCEPTANCE CRITERIA. DAMAGED ON THE LUER THREAD OBSERVED ON ONE OF THE SAMPLES, THEREFORE MEASUREMENT RESULTS WERE NOT ACCURATE. ADDITIONALLY, FOUR RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, NO DAMAGE OR DEFECTS OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, SAMPLE WAS ATTACHED TO A SYRINGE+ A PROTECTOR CONNECTED TO A VIAL. AFTER ASPIRATING THE COLORANT FROM THE VIAL TO THE SYRINGE, NO ISSUES OR LEAKAGE WERE FOUND ON THE INJECTOR. NO LUER LOCK DISCONNECTION OCCURRED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2012310, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE ON THE PRODUCT. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND FOUND ALL PRODUCT MET REQUIRED SPECIFICATIONS. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N40-O) SEPARATED FROM THE B.BRAUN ANTI-SIPHON VALVE WHEN HOOKING UP THE PUMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PROCEEDED TO USE LOCKING INJECTOR (515056) ON PRIMARY IV LINE FOR HYDRATION. COMPONENTS BEING USED WERE NOT USING HAZARDOUS DRUGS. ONLY SODIUM CHLORIDE. LINE WAS PRIMED AND WHEN NURSE WENT TO HOOK UP TO THE PUMP DISCONNECTION OCCURRED WITH B.BRAUN ANTI-SIPHON VALVE".

    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 BD PHASEAL¿ OPTIMA INJECTOR (N40-O) SEPARATED FROM THE B.BRAUN ANTI-SIPHON VALVE WHEN HOOKING UP THE PUMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PROCEEDED TO USE LOCKING INJECTOR (515056) ON PRIMARY IV LINE FOR HYDRATION. COMPONENTS BEING USED WERE NOT USING HAZARDOUS DRUGS. ONLY SODIUM CHLORIDE. LINE WAS PRIMED AND WHEN NURSE WENT TO HOOK UP TO THE PUMP DISCONNECTION OCCURRED WITH B.BRAUN ANTI-SIPHON VALVE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226430 BD PHASEAL OPTIMA INJECTOR (N40-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515056 2012310 00382905150562

    Patients

    Seq Age Sex Outcome Treatment
    1