BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR

    MDR report key: 13003619 · Received December 14, 2021

    Report

    Report Number
    3003152976-2021-00813
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 15, 2021
    Report Date
    January 25, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905151027
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON THE PROTECTOR MEMBRANE, THE NEEDLE OF THE PROTECTOR PENETRATED THE RUBBER STOPPER PROPERLY, ALTHOUGH IT WAS OBSERVED THE NEEDLE PENETRATED THE VIAL OFF CENTER ON THE RUBBER STOPPER. FUNCTIONAL TESTING WAS PERFORMED, LIQUID INSIDE THE SYRINGE COULD SUCCESSFULLY MOVE TO THE VIAL AND BACK TO THE SYRINGE WITHOUT ISSUE, HOWEVER, A LEAKAGE BETWEEN THE PROTECTOR AND VIAL WAS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOT 2103110 NO DEVIATIONS OR NON-CONFORMANCES WAS IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL EVALUATIONS THROUGHOUT MANUFACTURING, INCLUDING LEAKAGE TESTING TO ENSURE THE QUALITY OF THE MEMBRANE, AND VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. BASED ON THE INVESTIGATION AND SAMPLE EVALUATION, IT WAS DETERMINED THIS INCIDENT WAS LIKELY DUE TO AN IMPROPER CONNECTION OF THE PROTECTOR ONTO THE VIAL.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED BD PHASEAL¿ PROTECTOR HAD ISSUES WITH LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A STRONG ANTIBIOTIC SPILL OCCURRED WHEN A LEAK OCCURRED BETWEEN THE BOTTLE AND A... PROTECTOR".

    Description of Event or Problem · 0

    IT WAS REPORTED BD PHASEAL¿ PROTECTOR HAD ISSUES WITH LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A STRONG ANTIBIOTIC SPILL OCCURRED WHEN A LEAK OCCURRED BETWEEN THE BOTTLE AND A... PROTECTOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896109 BD PHASEAL¿ PROTECTOR INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515102 2103110 30382905151027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown