BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P50

    MDR report key: 15505811 · Received September 29, 2022

    Report

    Report Number
    3003152976-2022-00449
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 7, 2022
    Report Date
    December 7, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905151058
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 2201118 AND 2202133, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF EACH LOT WERE USED FOR ADDITIONAL EVALUATION. PRODUCT WAS VISUALLY INSPECTED AND NO ISSUES WERE IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE PROTECTOR SAMPLES TO 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 WITH NO LEAKAGE INTO THE EXPANSION CHAMBER. 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 OUR INVESTIGATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2201118. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026. DEVICE MANUFACTURE DATE: 05-JAN-2022. MEDICAL DEVICE LOT #: 2202133. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. DEVICE MANUFACTURE DATE: 25-FEB-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P50 WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IS LEAKING DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P50 WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IS LEAKING DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2931247 BD PHASEAL¿ PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515105 SEE H.10 30382905151058

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown