BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA

    MDR report key: 8350350 · Received February 19, 2019

    Report

    Report Number
    3003152976-2019-00162
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    January 30, 2019
    Report Date
    April 9, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PICTURE WAS RECEIVED SHOWING THE INJECTOR ATTACHED TO THE PROTECTOR. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1805701, NO DEVIATIONS OR NON-CONFORMANCE'S RELATED TO THIS ISSUE WERE IDENTIFIED. FUNCTIONAL TEST WAS PERFORMED ON THREE (3) SAMPLES (*). THE INJECTOR WAS CONNECTED TO A SYRINGE AND ATTACHED TO THE PROTECTOR + VIAL, FOLLOWING INSTRUCTIONS EXPLAINED IN THE IFU. THE EXPANSION CHAMBER INFLATES PROPERLY IN ALL CASES. IT WAS POSSIBLE TO WITHDRAW LIQUID IN ALL CASES EVEN THOUGH IS CONFIRMED THAT WITHDRAW IS DIFFICULT. (*) RELATED COMPLAINT WAS INVESTIGATED AT THE SAME TIME. NO ISSUES DETECTED RELATED TO THE PROTECTOR (28 SAMPLES TAKEN FOR INVESTIGATION). EXPANSION CHAMBER WORKED PROPERLY. NO LEAK FOUND. INSPECTIONS AND TESTS ACCORDING TO PH-321, VISUAL INSPECTION OF INJECTORS TAKES PLACE DURING MANUFACTURING PROCESS. (THE CORRECT ASSEMBLY OF THE COMPONENTS AND THE ABSENCE OF FOREIGN MATTER ARE VERIFIED). A SITUATION ANALYSIS (SA# MPS-19-1349-SA) WAS INITIATED FOR THE INJECTOR COMPLAINTS WITH FURTHER DETAILS RELATED TO THE INVESTIGATION: ¿IT WAS OBSERVED THAT LUBRICATION IN THE MEMBRANE POCKET AND CANNULA MAY HAVE MIGRATED INTO THE CANNULA AND POTENTIALLY OCCLUDED THE FLOW LOCATION. THE BATCHES THAT DEMONSTRATED DIFFICULTY IN ASPIRATING WERE THEN EVALUATED FOR LUBRICATION CONSISTENCY. SEVERAL BATCHES DEMONSTRATED SIMILAR GELLIKE APPEARANCE AND HAVE BEEN PLACED ON A GLOBAL HOLD (E.G. INJECTOR LOT #1805701). REMAINING BATCHES WERE NOT PLACED ON GLOBAL HOLD BECAUSE THEY DIDN'T DEMONSTRATE DIFFICULTY IN ASPIRATION.¿

    Additional Manufacturer Narrative · 0

    CORRECTION: THE INFORMATION WAS RE-EVALUATED AND THE COMPLAINT DOES NOT MEET OUR MDR REPORTING CRITERIA. NO FLOW DURING MEDICATION PREPARATION MAY LEAD TO CUSTOMER DISSATISFACTION OR A DELAY IN PREPARATION AS A NEW CONNECTOR IS REQUIRED BUT IT IS UNLIKELY TO LEAD TO ANY DEGREE OF HARM/SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ OPTIMA THE INJECTOR WAS DIFFICULT TO WITHDRAW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ OPTIMA THE INJECTOR WAS DIFFICULT TO WITHDRAW.

    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 DURING USE OF THE BD PHASEAL¿ OPTIMA THE INJECTOR WAS DIFFICULT TO WITHDRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143076 BD PHASEAL¿ OPTIMA INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1805701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other