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

Catalog Number	444150
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd synapsys¿ informatics solution.
Additional Manufacturer Narrative
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
H.6.Investigation summary this statement is to summarize the investigation of a complaint involving synapsys.It was reported that synapsys was having blood culture transmission issues.No other issues were reported.Bd investigated the issue.Bd remoted in and found the bottle on the instrument.It was flagged and the information was present in synapsys.The bottle was flagged at 14:37 and removed but the result was not sent until 16:10.There was a network issue at the site where capacity of the server was increased at the same time.It is suspected that the delay in transmission was due to this issue.The issue could not be observed.This is an unconfirmed failure of a bd product.Review found that complaints of this type were under statistical control for the month of august.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.
Event or Problem Description
It was reported that while using bd synapsys¿ informatics solution delayed sending a positive result to the lis.No patient impact reported.

• 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 ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22895592
• Report Number: 1119779-2025-04360
• Device Sequence Number: 5986483
• Product Code: JQP
• UDI-Device Identifier: 00382904441500
• UDI-Public: (01)00382904441500
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 08/01/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2020
• 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