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	07/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd synapsys¿, sample 23270212201 appeared as a double record.No patient impact reported.The following information was provided by the initial reporter: "customer emailed saying that sample 23270212201 after opening it in synapsys was showing no plates pictures (empty).After troubleshooting remotely, it was found that the sample has two records in synapsys.So, searching the number gives the same sample twice and one of them has the plates images and the other doesn't.".
Additional Manufacturer Narrative
H.6.Investigation summary: this statement is to summarize the investigation of a complaint involving synapsys product number 444150, serial number (b)(6).According to information provided, a "double record" was identified in synapsys.One sample did not show any plates.No other issues were reported.During investigation, bd service personnel dialed in and located two records in synapsys for the affected sample.One contained the plate images, while the other did not.This situation was the result of having two default culture protocols under the same sample.Service cancelled the record without the images.Further review found that this sample had been scanned in 6 times in a short period of time.When there was no response from the lis interface.It was not able to be determined how two separate sample entries were created.There was, however, no indication of any synapsys relationship to this issue.Based on these findings, this case has been assessed as unconfirmed for a bd quality issue with an unknown root cause.Review found complaints of this type were under statistical control for the month of july.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.H3 other text : see h.10.

• 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: 17358147
• Report Number: 1119779-2023-00788
• Device Sequence Number: 6941288
• Product Code: JTC
• UDI-Device Identifier: 00382904441500
• UDI-Public: 00382904441500
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 07/18/2023

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: 07/04/2023
• Initial Report FDA Received Date: 07/20/2023
• 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