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	11/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial address: (b)(6).H6.Investigation summary : this statement is to summarize the investigation of a complaint involving synapsys.It was reported that the synapsys was not communicating with bactec.No other issues were reported.Bd investigated the issue.Synapsys only had a partial accession number.The accession number in synapsys did not match what was in the fx.This was corrected by associating the correction accession number.The messages were backed up in synapsys.The synapsys backlogged payloads were processed.The site had problems over the weekend.The data processor was restarted, and stuck messages were transferred.The issue is resolved.This is a confirmed failure with a bd product.Review found complaints of this type were below statistical control for the month of november.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¿ an unspecified number of partial accessions were associated to the sequence numbers, despite the full accession number presented in the instrument.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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20925741
• Report Number: 1119779-2024-00993
• Device Sequence Number: 15533686
• 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): 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
• Report Date (Section B): 12/03/2024

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: 11/22/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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