BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 20925741 · Received December 13, 2024

    Report

    Report Number
    1119779-2024-00993
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 22, 2024
    Report Date
    December 3, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL ADDRESS: (B)(6). H6. INVESTIGATION SUMMARY : THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION OF A COMPLAINT INVOLVING SYNAPSYS. IT WAS REPORTED THAT THE SYNAPSYS WAS NOT COMMUNICATING WITH BACTEC. NO OTHER ISSUES WERE REPORTED. BD INVESTIGATED THE ISSUE. SYNAPSYS ONLY HAD A PARTIAL ACCESSION NUMBER. THE ACCESSION NUMBER IN SYNAPSYS DID NOT MATCH WHAT WAS IN THE FX. THIS WAS CORRECTED BY ASSOCIATING THE CORRECTION ACCESSION NUMBER. THE MESSAGES WERE BACKED UP IN SYNAPSYS. THE SYNAPSYS BACKLOGGED PAYLOADS WERE PROCESSED. THE SITE HAD PROBLEMS OVER THE WEEKEND. THE DATA PROCESSOR WAS RESTARTED, AND STUCK MESSAGES WERE TRANSFERRED. THE ISSUE IS RESOLVED. THIS IS A CONFIRMED FAILURE WITH A BD PRODUCT. REVIEW FOUND COMPLAINTS OF THIS TYPE WERE BELOW STATISTICAL CONTROL FOR THE MONTH OF NOVEMBER. 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. REPORTS OF THIS TYPE WILL CONTINUE TO BE MONITORED. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SUPPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ AN UNSPECIFIED NUMBER OF PARTIAL ACCESSIONS WERE ASSOCIATED TO THE SEQUENCE NUMBERS, DESPITE THE FULL ACCESSION NUMBER PRESENTED IN THE INSTRUMENT. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936110 BD SYNAPSYS¿ NA JQP BECTON DICKINSON & CO. (SPARKS) 00382904441500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown