BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INJECTOR (N35-O)

    MDR report key: 8326154 · Received February 11, 2019

    Report

    Report Number
    3003152976-2019-00140
    Event Type
    Malfunction
    Date Received
    February 11, 2019
    Date of Event
    January 24, 2019
    Report Date
    April 10, 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

    H.6. INVESTIGATION SUMMARY: CORRECTION: THE INFORMATION WAS RE-EVALUATED AND THE COMPLAINT DOES NOT MEET OUR MDR REPORTING CRITERIA. COMPLAINT IS NOT REPORTABLE. 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PICTURES OR SAMPLES WERE RECEIVED FOR INVESTIGATION. SIX (6) RETAINED SAMPLES WERE TAKEN FOR INVESTIGATION. FUNCTIONAL TEST WAS PERFORMED ON SIX (6) SAMPLES (*). THE INJECTOR WAS CONNECTED TO A SYRINGE AND ATTACHED TO THE PROTECTOR + VIAL, FOLLOWING INSTRUCTIONS EXPLAINED IN THE IFU. RETAINED SAMPLES FOR POSSIBLE N35-O INJECTOR LOTS WERE USED (3 SAMPLES FOR LOT#1806708 AND 3 SAMPLES FOR LOT#1805701). THE EXPANSION CHAMBER INFLATES PROPERLY IN ALL CASES. IT WAS POSSIBLE TO WITHDRAW LIQUID IN ALL CASES. HOWEVER, USING INJECTOR LOT #1805701 WITHDRAW IS MORE DIFFICULT. NO ISSUES OBSERVED WITH INJECTOR LOT#1806708. RELATED COMPLAINTS WERE INVESTIGATED AT THE SAME TIME. NO ISSUES DETECTED RELATED TO THE PROTECTOR (31 SAMPLES TAKEN FOR INVESTIGATION). EXPANSION CHAMBER WORKED PROPERLY. 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 GELL LIKE 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 (E.G. INJECTOR LOT# 1806708)". CAPA 611499.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT '"INCREASED EFFORT" HAD TO BE USED WITH THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O) TO WITHDRAW MEDICATION IN CONJUNCTION WITH THE "60 CC SYRINGES".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT '"INCREASED EFFORT" HAD TO BE USED WITH THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O) TO WITHDRAW MEDICATION IN CONJUNCTION WITH THE "60 CC SYRINGES".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT '"INCREASED EFFORT" HAD TO BE USED WITH THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O) TO WITHDRAW MEDICATION IN CONJUNCTION WITH THE "60 CC SYRINGES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118017 BD PHASEAL¿ OPTIMA INJECTOR (N35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other