BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 15443627 · Received September 18, 2022

    Report

    Report Number
    1119779-2022-01201
    Event Type
    Malfunction
    Date Received
    September 18, 2022
    Date of Event
    September 5, 2022
    Report Date
    January 30, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    UDI-DI
    00382904441500
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2022-01201 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THE CUSTOMER WAS UNABLE TO VIEW CULTURES IN SYNAPSYS. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO VIEW CULTURES IN SYNAPSYS - SPINS THE WHEEL AND THEN AN INTERNAL SERVER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THE CUSTOMER WAS UNABLE TO VIEW CULTURES IN SYNAPSYS. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO VIEW CULTURES IN SYNAPSYS - SPINS THE WHEEL AND THEN AN INTERNAL SERVER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2522754 BD SYNAPSYS¿ NA JQP BECTON, DICKINSON & CO. (SPARKS) 00382904441500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown