BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DISPOSABLE SET

    MDR report key: 19199068 · Received April 28, 2024

    Report

    Report Number
    9616066-2024-00654
    Event Type
    Malfunction
    Date Received
    April 28, 2024
    Date of Event
    April 4, 2024
    Report Date
    July 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF CONNECTION ISSUES - DISCONNECTION COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    DURING A VOICE OF CUSTOMER STUDY THE FOLLOWING FEEDBACK WAS RECEIVED: CLINICIAN (RADIOLOGIC TECHNICIAN) SAID EXTENSION TUBING CONNECTED TO AUTOGUARD PRODUCT WOULD POP OFF OR GET LOOSE DURING POWER INJECTION. COMMENT OBSERVED DURING A VOICE OF CUSTOMER RESEARCH STUDY. COMMENT WAS GENERAL IN NATURE. CLINICIAN WAS NOT REFERENCING A SPECIFIC EVENT DID NOT SPECIFY WHICH CONNECTOR. CLINICIAN EXPRESSED SOME DOUBT THAT THE EXTENSION TUBING PLACED IN THE EMERGENCY DEPARTMENT OR BY THE EMT WAS RATED FOR POWER INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865551 UNKNOWN DISPOSABLE SET SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown