BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUC 4 OS IMG IOT10/EPI 4.0

    MDR report key: 16766402 · Received April 18, 2023

    Report

    Report Number
    1119779-2023-00444
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 24, 2023
    Report Date
    April 21, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER E-MAIL: (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

    H.6 INVESTIGATION SUMMARY: THE CUSTOMER HAS ASSOCIATED A TUBE WITH A WRONG ID (444165/(B)(6) ). THE CUSTOMER WAS GUIDED ON HOW TO RE-ASSOCIATE THE TUBE TO THE CORRECT ID. THIS IS NOT A CONFIRMED COMPLAINT OF A BD PRODUCT. COMPLAINTS FOR SOFTWARE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF MARCH. NO TRENDS INDICATED. DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED FOR STANDALONE SOFTWARE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE NUC 4 OS IMG IOT10/EPI 4.0 THAT THERE WAS AN INCREASED POTENTIAL FOR MIS-ASSOCIATION DUE TO USE ERROR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEW VALUE: GUIDED THE CUSTOMER IN THE CHANGE OF ASSOCIATION, REQUESTED INTERVENTION OF APPLICATION SPECIALISTS, OPERATING SYSTEM ACCORDING TO BD SPECIFICATIONS. THE CUSTOMER HAS ASSOCIATED A TUBE WITH A WRONG ID.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE NUC 4 OS IMG IOT10/EPI 4.0 THAT THERE WAS AN INCREASED POTENTIAL FOR MIS-ASSOCIATION DUE TO USE ERROR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEW VALUE: GUIDED THE CUSTOMER IN THE CHANGE OF ASSOCIATION, REQUESTED INTERVENTION OF APPLICATION SPECIALISTS, OPERATING SYSTEM ACCORDING TO BD SPECIFICATIONS. THE CUSTOMER HAS ASSOCIATED A TUBE WITH A WRONG ID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601945 NUC 4 OS IMG IOT10/EPI 4.0 NOT CLASSIFIED JQP BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown