BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 19524629 · Received June 12, 2024

    Report

    Report Number
    1119779-2024-00500
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    April 29, 2024
    Report Date
    May 20, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    UDI-DI
    00382904441500
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION OF A COMPLAINT INVOLVING SYNAPSYS. IT WAS REPORTED THAT SYNAPSYS REPORT DOES NOT MATCH THE INSTRUMENT FXS BOTTLE STATUS. THE CUSTOMER REPORTS THAT THERE WERE FALSE POSITIVES, BUT SYNAPSYS REFLECTS THAT THE BOTTLES WERE NEGATIVE. NO OTHER ISSUES WERE REPORTED. BD INVESTIGATED THE ISSUE. THE INVESTIGATION DETERMINED THAT THE SYNAPSYS WORKS AS DESIGNED. THE ISSUE IS DUE TO THE LIS. THIS IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. REVIEW FOUND COMPLAINTS ANALYZED UNDER 'APPLICATIONS' AND 'INTERFACING' CODES WERE ABOVE STATISTICAL CONTROL FOR THE MONTH OF MAY. A CAPA WILL ADDRESS THIS ISSUE TO IMPROVE THE AFFECTED PRODUCT AND/OR PROCESSES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THE REPORT PRESENTED INCORRECT RESULTS. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161583 BD SYNAPSYS¿ NA JQP BECTON DICKINSON & CO. (SPARKS) 00382904441500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown