BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿ INFORMATICS SOLUTION

    MDR report key: 24349787 · Received February 16, 2026

    Report

    Report Number
    1119779-2026-00148
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 25, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    UDI-DI
    00382904441500
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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

    THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION OF A COMPLAINT INVOLVING SYNAPSYS. IT WAS REPORTED THAT SYNAPSYS COULD NOT FIND A DISH THAT WAS FOUND IN READA OVERVIEW. NO OTHER ISSUES WERE REPORTED. BD INVESTIGATED THE ISSUE. BD WROTE AN EMAIL OF FINDINGS OF THE INVESTIGATION, WHICH WERE THE LOCATION OF THE PLATE AND EXPLANATION OF LOCATION INFORMATION IN SYNAPSYS UI. THE CUSTOMER WAS SATISFIED WITH THE EMAIL. SYNAPSYS WORKS AS DESIGNED. THIS IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. REVIEW FOUND THAT COMPLAINTS OF THIS TYPE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF JANUARY. DEVICE HISTORY RECORD REVIEW WAS NOT APPLICABLE AS THIS IS A STANDALONE SOFTWARE PRODUCT, AND THE OPERATION/FUNCTIONALITY OF THIS TYPE OF PRODUCT IS CONFIRMED AT THE TIME OF INSTALLATION. NO CAPA. NO NEW HAZARDS OR RISKS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION, A PATIENT'S SPECIMEN WORKUP DISH COULD NOT BE FOUND IN THE SYSTEM. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ INFORMATICS SOLUTION, A PATIENT'S SPECIMEN WORKUP DISH COULD NOT BE FOUND IN THE SYSTEM. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504293 BD SYNAPSYS¿ INFORMATICS SOLUTION CALCULATOR/DATA PROCESSING MODULE JQP BECTON DICKINSON & CO. (SPARKS) 00382904441500

    Patients

    Seq Age Sex Outcome Treatment
    1