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	09/12/2023
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 bd synapsys¿ that there was an application error that affects patients samples, that did not alert the user.The following information was provided by the initial reporter: customer reached out stating 5 am trigger time was not working for no growth messages to the lis for the 5 day final message.The customer stated the 4 pm trigger time was the only time they say the 5 day final messages and the trigger times were fine for the preliminary messages.The customer normally pulls bottles between 6 am and 4 pm, this means that those would be triggered at the 4 pm timeframe since that in the next trigger time and unlike the preliminary messages, they do not require the culture to be completed like the 5 day final rule that is set for this install.I did confirm that there were instances where results were triggered at 5 am when bottles were pulled between 4 pm and 5 am.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2023-01078 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.
Event or Problem Description
It was reported that while using bd synapsys¿ that there was an application error that affects patients samples, that did not alert the user.The following information was provided by the initial reporter: customer reached out stating 5 am trigger time was not working for no growth messages to the lis for the 5 day final message.The customer stated the 4 pm trigger time was the only time they say the 5 day final messages and the trigger times were fine for the preliminary messages.The customer normally pulls bottles between 6 am and 4 pm, this means that those would be triggered at the 4 pm timeframe since that in the next trigger time and unlike the preliminary messages, they do not require the culture to be completed like the 5 day final rule that is set for this install.I did confirm that there were instances where results were triggered at 5 am when bottles were pulled between 4 pm and 5 am.

• 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: 17913683
• Report Number: 1119779-2023-01078
• Device Sequence Number: 7405380
• Product Code: JQP
• UDI-Device Identifier: 00382904441500
• UDI-Public: 00382904441500
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/27/2023

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: 09/12/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/10/2023
• 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