BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA PROTECTOR (P20-O)

    MDR report key: 8355706 · Received February 20, 2019

    Report

    Report Number
    3003152976-2019-00169
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 30, 2019
    Report Date
    April 9, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150647
    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: ONE PICTURE WAS RECEIVED SHOWING SOME DROPS THROUGH THE HYDROPHOBIC FILTER. NO SAMPLES ARE AVAILABLE FOR INVESTIGATION. THIRTY-ONE (31) RETAINED SAMPLES WERE TAKEN FOR INVESTIGATION. VISUAL INSPECTION REVEALS NO DEFECTS. TWENTY (25) SAMPLES WERE INFLATED THROUGH THE SPIKE USING A SYRINGE WITH 50 ML OF AIR. ALL OF THE SAMPLES EXPANDED THE CHAMBER PROPERLY AND NO DEFECTS WERE FOUND ON THE FILM. 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. IN ALL CASES EXPANSION CHAMBER WORKED PROPERLY (INFLATED AND DEFLATED PROPERLY). NO LEAK WAS FOUND THROUGH THE HYDROPHOBIC FILTER. INSPECTIONS AND TESTS: ACCORDING TO PH-322, VISUAL INSPECTION OF PROTECTOR TAKES PLACE DURING MANUFACTURING PROCESS. (THE CORRECT ASSEMBLY OF THE COMPONENTS AND THE ABSENCE OF FOREIGN MATTER ARE VERIFIED). ACCORDING TO PH-322 LEAK TEST AND BURST TEST ARE PERFORMED ON THE FIRST LOT OF EACH MONTH USING A Z-AXIS EQUIPMENT. THE VOLUME OF THE EXPANSION CHAMBER IS CHECKED ON THE FIRST LOT OF EACH MONTH ACCORDING TO PH-322/PC-225 AS WELL. THE MACHINE HAS A LEAK TEST AND FLOW TEST, BOTH TESTS WILL DETECT IF THE SAMPLE HAS THE CHANNELS 100% BLOCKED IN SUCH A WAY THAT HE CHAMBERS CAN´T BE INFLATED. FLOW TEST WILL DETECT THE BAD SAMPLE SINCE THE FLOW RATE WILL BE 0 L/MIN. LEAK TEST WILL DETECT THE BAD SAMPLES SINCE THE CHAMBER WILL NOT BE THERMOFORMED AND CONSEQUENTLY, THE LEAK TEST WILL FAIL OR EVEN WILL NOT START. THE ROOT CAUSE OF THE DEFECT MAY BE RELATED TO DEFECTIVE INJECTORS. 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. REMAINING BATCHES WERE NOT PLACED ON GLOBAL HOLD BECAUSE THEY DIDN¿T DEMONSTRATE DIFFICULTY IN ASPIRATION.¿ IF PROTECTORS WERE USED WITH DEFECTIVE INJECTORS, OCCLUSION MAY AVOID THE PROPERLY WORK OF THE PROTECTOR CHAMBER.

    Additional Manufacturer Narrative · 0

    THE INFORMATION WAS RE-EVALUATED AND THE COMPLAINT DOES NOT MEET OUR MDR REPORTING CRITERIA. WHEN THE EXPANSION CHAMBER DOES NOT DEFLATE, THIS MAY LEAD TO CUSTOMER DISSATISFACTION OR A DELAY IN PREPARATION, BUT IT IS UNLIKELY TO LEAD TO ANY DEGREE OF HARM/SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PHASEAL OPTIMA PROTECTOR (P20-O) EXPANSION CHAMBER DID NOT DEFLATE. A PLUG WAS NOTICED IN THE EXPANSION CHAMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PHASEAL OPTIMA PROTECTOR (P20-O) EXPANSION CHAMBER DID NOT DEFLATE. A PLUG WAS NOTICED IN THE EXPANSION CHAMBER.

    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 A BD PHASEAL OPTIMA PROTECTOR (P20-O) EXPANSION CHAMBER DID NOT DEFLATE. A PLUG WAS NOTICED IN THE EXPANSION CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149489 BD PHASEAL OPTIMA PROTECTOR (P20-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1807701 00382905150647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other