BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ NEEDLE-FREE VALVE

    MDR report key: 15601258 · Received October 13, 2022

    Report

    Report Number
    9616066-2022-01540
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 20, 2022
    Report Date
    October 27, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FIRST NAME: (B)(6). INITIAL REPORTER PHONE #: (B)(6). 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: 17-NOV-2022. INVESTIGATION SUMMARY ONE 2000E7D SAMPLE FROM LOT 1022883 WAS RECEIVED FOR INVESTIGATION. THE CUSTOMER HAS REPORTED LEAKAGE "THROUGH THE RUBBER IN THE CONNECTOR". FURTHER DETAILS RELATING TO THE NATURE OF THE REPORTED LEAKAGE, THE CLINICAL SET UP, AND SEQUENCE OF EVENTS PRIOR TO THE LEAKAGE OCCURRING WERE NOT PROVIDED TO AID THE INVESTIGATION. EXAMINATION OF THE RETURNED SAMPLE NOTED NO PHYSICAL DAMAGE OR DEFORMITY WHICH MIGHT EXPLAIN THE CUSTOMER'S EXPERIENCE. FUNCTIONAL TESTING PERFORMED ON THE SAMPLE OBSERVED NO FLUID LEAKAGE OR AIR INGRESS FROM THE COMPONENT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1022883 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE IN THIS INSTANCE. TESTING OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE VALVE EXPERIENCED LEAKAGE, AND BLOOD EXPOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGESE: THE CONNECTOR HAS PRESENTED PROBLEMS WITH TWO BABIES IN THE UNIT, BLOOD LEAKING THROUGH THE RUBBER IN THE CONNECTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE VALVE EXPERIENCED LEAKAGE, AND BLOOD EXPOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGESE: THE CONNECTOR HAS PRESENTED PROBLEMS WITH TWO BABIES IN THE UNIT, BLOOD LEAKING THROUGH THE RUBBER IN THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889176 BD SMARTSITE¿ NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1022883

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown