BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA

    MDR report key: 7970639 · Received October 16, 2018

    Report

    Report Number
    3003152976-2018-00453
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    September 25, 2018
    Report Date
    November 9, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FOZ
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DHR- NO NON-CONFORMANCES OR OTHER EVENTS RELATED TO THE CLAIMED DEFECT WERE FOUND IN CLAIMED LOT 1805707 (N35-O ASSEMBLY LOTS 1801702, 1801708). 40 UNOPENED INJECTORS WERE RECEIVED FOR INVESTIGATION. A VIDEO WAS ALSO RECEIVED. FLOW ISSUES/LEAKAGE OTHERS. 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). PENETRATION BACK PRESSURE TEST IS DONE TO ENSURE THAT AFTER 10 PENETRATIONS, INJECTOR MEMBRANE SHALL WITHSTAND A BACK PRESSURE, P (P=29 PSI), WITHOUT LEAKAGE (ACCORDING TO PH-500 AND IT-10000204107). ASSESSMENT OF UNUSED COMPLAINT SAMPLES. ON VIDEO RECEIVED, THE INJECTOR IS CONNECTED TO THE SYRINGE. ONCE THE SYRINGE IS PRESSED, A LEAK TROUGH THE MEMBRANE APPEARED AS THE INJECTOR IS NOT ATTACHED TO ANY OTHER DEVICE. IN ORDER TO CONFIRM THAT THE LEAKAGE WAS NOT DUE TO A FAILURE IN THE MEMBRANE, PENETRATION BACK PRESSURE TEST WAS PERFORMED IN 30 SAMPLES. IN ALL CASES, THE SPECIFICATION WAS MET (P= 29 PSI). IN ORDER TO REPLICATE THE FLOW ISSUE EXPERIENCE, UNUSED SAMPLES FROM THE COMPLAINT N35-O BATCH WERE TESTED. THE PRODUCTS WERE USED FOLLOWING INSTRUCTIONS INCLUDED IN THE IFU, TAKING INTO ACCOUNT THAT ¿IF ASPIRATION DRUG FROM A VIAL, DRAW A VOLUME OF AIR EQUIVALENT TO THE DOSE INTO THE SYRINGE¿. IN THIS CASE, THE METHOD WAS THE FOLLOWING ONE: 1.SET A 60ML SYRINGE TO 40ML OF AIR, ATTACH TO INJECTOR. 2.INJECT ALL 40ML OF AIR INTO SYSTEM. 3.WITHDRAW 40ML OF WATER. IT WAS POSSIBLE TO DRAW THE LIQUID FROM THE VIAL EVEN TOUGH FOLLOW ISSUES ARE CONFIRMED. THE N35-O SAMPLES WERE DISASSEMBLED AND LUBRICATION ON THE CANNULA APPEARED TO BE GEL-LIKE THAT MAY HAVE BEEN BLOCKING THE FLUID PATH. THE LUBE WAS REMOVED FROM INSIDE OF THE CANNULA AND PLACED ON A GLASS SLIDE FOR EVALUATION. VARYING N35-O LOTS WITH SIMILAR FLOW ISSUES ALSO APPEARED TO BE GEL-LIKE WHEN DISASSEMBLED AND PLACED ON A GLASS SLIDE AS DESCRIBED IN PRN# (B)(4). INVESTIGATION CONCLUSION: THE LEAKAGE FOUND IN THE INJECTOR IS POTENTIALLY DUE TO A MISUSE OF THE INJECTOR, AS THE INJECTOR WAS NOT CONNECTED TO ANOTHER DEVICE. IT MUST BE TAKING INTO ACCOUNT THAT THE NUMBER OF PUNCTURES PERFORMED TO THE MEMBRANE ARE UNKNOWN. THE RESULTS OF THE PENETRATION BACK PRESSURE TEST CONFIRM THAT THE QUALITY REQUIREMENTS ARE MET. RELATED TO FLOW ISSUES, PROBABLE ROOT CAUSE IS ON-GOING FOR N35-O. A SITUATION ANALYSIS (SA# (B)(4) IS BEING INITIATED FOR THE INJECTOR WITH FURTHER DETAILS RELATED TO THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿ OPTIMA WHEN PRESSURE IS SET ON SYRINGE WITH INJECTOR FLUID IS LEAKING HEAVILY THROUGH THE SEPTUM. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    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 WITH THE USE OF THE BD PHASEAL¿ OPTIMA WHEN PRESSURE IS SET ON SYRINGE WITH INJECTOR FLUID IS LEAKING HEAVILY THROUGH THE SEPTUM. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808917 BD PHASEAL¿ OPTIMA INJECTOR FOZ BECTON DICKINSON, S.A. 1805707

    Patients

    Seq Age Sex Outcome Treatment
    1 Other