BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P55

    MDR report key: 13213303 · Received January 10, 2022

    Report

    Report Number
    3003152976-2021-00892
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Date of Event
    December 15, 2021
    Report Date
    March 30, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905151171
    PMA / PMN Number
    K130197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    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-MAR-2022. H6: INVESTIGATION SUMMARY: PROTECTOR, INJECTOR, VIAL, AND SYRINGE RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION IT CAN BE CONFIRMED THAT LEAKS ARE PRESENT IN THE FILTER OF THE PROTECTOR, THE FILTER APPEARS OVERSATURATED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2102118 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. IF THE PROTECTOR IS USED MORE THAN ONCE, LIQUID MAY ACCUMULATE AND OVERSATURATE THE FILTER. THIS OVERSATURATION WOULD CREATE A PRESSURE WHICH PREVENTED PROPER AIR RELEASE TO THE EXPANSION CHAMBER. THE SAME EFFECT MAY OCCUR IF LIQUID ACCUMULATED WITHIN THE INTERNAL FACE OF THE VIAL RUBBER STOPPER, OVERPRESSURE COULD THEN CREATE A LEAK INTO THE EXPANSION CHAMBER. THE PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED 2 BD PHASEAL¿ PROTECTOR P55S HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...ITS FLUID LEAKED FROM THE CONNECTION TO THE VIAL."

    Description of Event or Problem · 0

    IT WAS REPORTED 2 BD PHASEAL¿ PROTECTOR P55S HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...ITS FLUID LEAKED FROM THE CONNECTION TO THE VIAL."

    Description of Event or Problem · 0

    IT WAS REPORTED 2 BD PHASEAL¿ PROTECTOR P55S HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...ITS FLUID LEAKED FROM THE CONNECTION TO THE VIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985504 BD PHASEAL¿ PROTECTOR P55 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515117 2102118 30382905151171

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown