MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD SYNAPSYS¿

Catalog Number 444150

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

Event Type  malfunction  

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 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.

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 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¿
• Type of Device: 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
• MDR Text Key: 325407897
• Report Number: 1119779-2023-01078
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 444150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1