MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD SYNAPSYS¿ INFORMATICS SOLUTION; CALCULATOR/DATA PROCESSING MODULE

Catalog Number	444150
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd synapsys¿ informatics solution, rule bd10021 was marking cultures without an organism id as contaminants.No patient impact reported.
Event or Problem Description
It was reported that while using bd synapsys¿ informatics solution, rule bd10021 was marking cultures without an organism id as contaminants.No patient impact reported.
Additional Manufacturer Narrative
H.6.Investigation summary: this statement is to summarize the investigation of a complaint involving synapsys.It was reported that the synapsys contamination rule was firing incorrectly.No other issues were reported.Bd investigated the issue.The blood culture contamination rule bd10021 was marking contaminates inappropriately.This is caused by a software bug and will be fixed in a future synapsys release.This can be tracked by a system change request.This was a confirmed failure of bd product.Review found complaints of this type were below statistical control for the month of may.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.

• Brand Name: BD SYNAPSYS¿ INFORMATICS SOLUTION
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: matt j. connor ; 1575 airport road; sumter, SC 29153 ; 8015652341
• MDR Report Key: 22345140
• Report Number: 1119779-2025-00729
• Device Sequence Number: 4901085
• Product Code: JQP
• UDI-Device Identifier: 00382904441500
• UDI-Public: (01)00382904441500(11)231013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 444150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown