BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 17821285 · Received September 26, 2023

    Report

    Report Number
    1119779-2023-01030
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    August 31, 2023
    Report Date
    November 3, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    UDI-DI
    00382904441500
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION OF A COMPLAINT INVOLVING SYNAPSYS. ACCORDING TO INFORMATION PROVIDED, THE SYNAPSYS HAD ANONYMOUS DOUBLE ENTRIES. NO OTHER ISSUES WERE REPORTED. BD SERVICE PERSONNEL INVESTIGATED THE ISSUE. THE SECOND ENTRY HAD THE SEQUENCE AND SAMPLE NUMBER IN SYNAPSYS. THIS ISSUE DID NOT ADVERSELY IMPACT THE PATIENT. THIS ISSUE WAS CAUSED BY A SOFTWARE BUG AND WILL BE FIXED IN A FUTURE RELEASE. IT WILL BE TRACKED UNDER A SYSTEM CHANGE REQUEST. THIS IS A CONFIRMED FAILURE OF A BD PRODUCT. REVIEW FOUND COMPLAINTS OF THIS TYPE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF SEPTEMBER. ADDITIONALLY, NO ADVERSE TREND WAS IDENTIFIED FOR REPORTS OF THIS TYPE. 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THAT THERE WAS INCORRECT DATA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYNAPSYS ANONYMOUS DOUBLE ENTRY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THAT THERE WAS INCORRECT DATA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYNAPSYS ANONYMOUS DOUBLE ENTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985417 BD SYNAPSYS¿ NA JQP BECTON DICKINSON & CO. (SPARKS) 00382904441500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown