MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD SYNAPSYS¿; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

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	10/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd synapsys that there was incorrect data.The following information was provided by the initial reporter: syn : cnumbers in synapsys not matching with molis.Impact: no adverse impact on healthcare professionals and patients.
Event or Problem Description
It was reported that while using the bd synapsys that there was incorrect data.The following information was provided by the initial reporter: syn : numbers in synapsys not matching with molis.Impact: no adverse impact on healthcare professionals and patients.
Additional Manufacturer Narrative
H.6.Investigation summary: this statement is to summarize the investigation of a complaint involving synapsys.It was reported that synapsys c numbers do not match is their lis.No other issues were reported.Bd service personnel investigated the issued.This issue was caused by a software bug which caused a drop in communication to lis.This leads to a backlog of communications of messages which informed the lis of a container number change.This was resolved by increasing the inactivity timer until the fix is released in a future synapsys release.This issue can be tracked by system change request 9109367.This is a confirmed failure of a bd product.Review found complaints of this type were under statistical control for the month of october.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.Reports of this type will continue to be monitored.However, as there is no evidence of any new adverse trend, hazard or risk, no additional action is currently indicated.
Event or Problem Description
It was reported that while using the bd synapsis that there was incorrect data.The following information was provided by the initial reporter: syn : numbers in synapsis not matching with molis.Impact: no adverse impact on healthcare professionals and patients.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report # 1119779-2023-01220 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.

• Brand Name: BD SYNAPSYS¿
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• 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: 18134634
• Report Number: 1119779-2023-01220
• Device Sequence Number: 12400537
• Product Code: JQP
• UDI-Device Identifier: 00382904441500
• UDI-Public: (01)00382904441500
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 01/08/2024

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: 10/20/2023
• Supplement Date Received by Manufacturer: 12/08/2023; 01/08/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/22/2023; 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• 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