BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P13-O

    MDR report key: 16695314 · Received April 6, 2023

    Report

    Report Number
    3002682307-2023-00092
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 17, 2023
    Report Date
    June 30, 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

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 30-JUN-2023. H6: INVESTIGATION SUMMARY SAMPLE AND PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, FOREIGN MATTER IS OBSERVED ON THE FILM OF EXPANSION CHAMBER. FOREIGN MATTER IS MAINLY COMPOSED BURNT MATERIAL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2201414, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THREE RETAINED SAMPLES WERE USED FOR ADDITIONAL EVALUATION. NO DAMAGE OR OTHER DEFECTS WAS OBSERVED ON ANY OF THE PRODUCT. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE INJECTOR TO A SAMPLE SYRINGE, PROTECTOR AND VIAL ACCORDING TO THE INSTRUCTIONS FOR USE. LIQUID WAS ASPIRATED FROM THE VIAL, DISCONNECTING THE INJECTOR FROM THE PROTECTOR AND REPEATING THE PROCESS THREE TIMES. IN ALL CASES, THE PRODUCT FUNCTIONED PROPERLY AND THERE WERE NO ISSUES OBSERVED BETWEEN THE CONNECTION OF THE INJECTORS AND PROTECTOR. 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 AVAILABLE INFORMATION, POSSIBLE ROOT CAUSE IS ASSOCIATED WITH BURNT MATERIAL AT THE FILM SEALING STATION IN THE EXPANSION CHAMBER. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P13-O EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS LOOKS LIKE LITTLE WHITE PARTICLES THAT ARE ON THE CSTD ITSELF. I¿VE ATTACHED A PHOTOGRAPH OF THE INJECTOR WHERE THIS HAS HAPPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P13-O EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS LOOKS LIKE LITTLE WHITE PARTICLES THAT ARE ON THE CSTD ITSELF. I¿VE ATTACHED A PHOTOGRAPH OF THE INJECTOR WHERE THIS HAS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518833 BD PHASEAL¿ PROTECTOR P13-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515060 2201414 00382905150609

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown