BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA PROTECTOR P13-O

    MDR report key: 17131479 · Received June 14, 2023

    Report

    Report Number
    3003152976-2023-00233
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 23, 2023
    Report Date
    August 1, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150609
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PICTURE, THE PROTECTOR IS ASSEMBLED IN THE VIAL, BUT THE RUBBER STOPPER HAS BEEN DISASSEMBLED FROM THE VIAL AND HAS FALLEN INTO THE MEDICINE VIAL. THROUGH VISUAL EVALUATION OF THE SAMPLES, NO DEFECTS OR ISSUES OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE PROTECTOR SAMPLE TO BOTH A VIAL, INJECTOR, AND SYRINGE PER THE INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT. IN ALL CASES THE EXPANSION CHAMBER EXPANDED PROPERLY, LIQUID WAS ABLE TO BE DRAWN FROM THE VIAL, AND THE PRODUCT FUNCTIONED AS INTENDED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2111401, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THREE RETAINED SAMPLES FROM THE LOT WERE EVALUATED, NO DEFECTS OR ISSUES OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE PROTECTOR SAMPLE TO BOTH A VIAL, INJECTOR, AND SYRINGE PER THE INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT. IN ALL CASES THE EXPANSION CHAMBER EXPANDED PROPERLY, LIQUID WAS ABLE TO BE DRAWN FROM THE VIAL, AND THE PRODUCT FUNCTIONED AS INTENDED. PRODUCT UNDERGOES A SERIES OF TESTING DURING MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. THESE TESTS INCLUDE VISUAL INSPECTIONS ALONG WITH LEAKAGE TESTING AND FLOW RATE, ALL RECORDS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD PHASEAL¿ OPTIMA PROTECTOR P13-O THE RUBBER STOPPER DISLODGES INTO VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OPTIMA ASSEMBLY FIXTURE WAS USED WITH THE P13-O TO SPIKE A VIAL OF VECTIBIX. THIS VIAL HAS A FLAT VIAL STOPPER. THIS WAS A VETERAN STAFF MEMBER WHOM IS FAMILIAR WITH THIS SYSTEM. THE RUBBER STOPPER PUSHED ALL THE WAY INTO THE VIAL. THIS IS THE FIRST TIME THIS HAS HAPPENED WITH THIS VIAL AND OUR P13-O.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD PHASEAL¿ OPTIMA PROTECTOR P13-O THE RUBBER STOPPER DISLODGES INTO VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OPTIMA ASSEMBLY FIXTURE WAS USED WITH THE P13-O TO SPIKE A VIAL OF VECTIBIX. THIS VIAL HAS A FLAT VIAL STOPPER. THIS WAS A VETERAN STAFF MEMBER WHOM IS FAMILIAR WITH THIS SYSTEM. THE RUBBER STOPPER PUSHED ALL THE WAY INTO THE VIAL. THIS IS THE FIRST TIME THIS HAS HAPPENED WITH THIS VIAL AND OUR P13-O

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281466 BD PHASEAL¿ OPTIMA PROTECTOR P13-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515060 2111401 00382905150609

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown