MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD SYNAPSYS¿

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	04/15/2024
Type of Reportable Event	Malfunction
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.H3 other text : see h.10.
Event or Problem Description
It was reported that while using bd synapses¿ the plate images shown for one patient sample number appeared under a different patient sample number.No patient impact reported.
Additional Manufacturer Narrative
Investigation summary: this statement is to summarize the investigation of a complaint involving synapsys.It was reported that the plate images for the wrong patient sample was appearing.No other issues were reported.Bd investigated the issue.The iis filter size was increased from 30 m to 50 m and restarted iis to resolve the error message.The sample appeared under a different lab number.This issue was caused by a software bug and will be fixed in a future synapsys release.This can be tracked by a system change request.This is a confirmed failure of a bd product.Review found complaints of this type were above statistical control for the month of april.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.Capa was created for the high severity hazard.This site was part of the field action initiated by bd.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¿ the plate images shown for one patient sample number appeared under a different patient sample number.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 plate images for a sample appeared under a different lab number.Bd investigated this issue, and it was determined that the demographic data failed to refresh when the user moves to the next sample.This was captured under the system change request (b)(4).This is a confirmed failure of a bd product.The customer was upgraded to (b)(4) to resolve the issue.Review found that complaints of this type were below statistical control for the month of april.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¿ the plate images shown for one patient sample number appeared under a different patient sample number.No patient impact reported.

• Brand Name: BD SYNAPSYS¿
• Common Device Name: NA
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19310065
• Report Number: 1119779-2024-00378
• Device Sequence Number: 3076693
• 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): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2025

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: 04/15/2024
• Supplement Date Received by Manufacturer: 09/17/2024; 09/15/2025
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 10/03/2024; 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2021
• 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