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	09/01/2023
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.
Event or Problem Description
It was reported that while using bd synapsys¿ there was misassociation of one sample.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting description of lis transmission hx from one of the technologists "the tech skipped a culture (70ob23677545) and when the new patient populated on the kiestra screen (10ob23682401), it didn't populate on the cerner screen.The tech then resulted the culture and the results went to the previous culture which was skipped.".
Event or Problem Description
It was reported that while using bd synapsys¿ there was misassociation of one sample.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting description of lis transmission hx from one of the technologists "the tech skipped a culture (70ob23677545) and when the new patient populated on the kiestra screen (10ob23682401), it didn't populate on the cerner screen.The tech then resulted the culture and the results went to the previous culture which was skipped.".
Additional Manufacturer Narrative
H6.Investigation summary: this statement is to summarize the investigation of a complaint involving bd synapsys.According to the information provided, the customer reported that they had an lis transmission issue.This resulted in incorrect results reporting in the lis.No other issues were reported.During investigation, bd found out that the customer resulted the incorrect culture.This was due to a workflow issue as they did not wait until the lis screen changed.Synapsys worked as designed.This was an unconfirmed failure of a bd product.Review found complaints of this type were under statistical control for the month of september.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.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17835521
• Report Number: 1119779-2023-01033
• Device Sequence Number: 7760502
• Product Code: JQP
• UDI-Device Identifier: 00382904441500
• UDI-Public: 00382904441500
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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: 09/01/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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