BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS EXTENSION SET

    MDR report key: 17738156 · Received September 13, 2023

    Report

    Report Number
    9616066-2023-01878
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    July 17, 2023
    Report Date
    October 23, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403234901
    PMA / PMN Number
    K790108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PHOTO OR SAMPLE WAS RECEIVED FOR THE CUSTOMER'S COMPLAINT OF LEAKAGE. WITHOUT FURTHER INFORMATION LIKE A PHYSICAL SAMPLE FOR INVESTIGATION, THE COMPLAINT CANNOT BE VERIFIED AND ROOT CAUSE OF THIS FAILURE REMAINS UNKNOWN. A DEVICE HISTORY RECORD REVIEW FOR MODEL 20129E LOT NUMBER 22019236 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON (B)(6) 2022. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE BUILD OF THIS SET. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: LEAKING LIPIDS (IN CENTRAL LINE OF PATIENT) AT FILTER. PRODUCT BECTON DICKINSON AND COMPANY EXTENSION SET SMALLBORE TUBING 1.2 MICRON LOW PROTEIN BINDING FILTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: LEAKING LIPIDS (IN CENTRAL LINE OF PATIENT) AT FILTER. PRODUCT BECTON DICKINSON AND COMPANY EXTENSION. SET SMALLBORE TUBING 1.2 MICRON LOW PROTEIN BINDING FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85057 BD ALARIS EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 22019236 50885403234901

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown