MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AST-S INDICATOR SOLUTION; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Model Number	246009
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	06/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd phoenix¿ ast-s indicator solution, the proper reagent amount would not afford a reaction and insufficient, solution error would display.This is a report of a single occurrence.There were no results to report out to the clinician or to the patient.The following information was provided by the initial reporter: according to the customer's report, even though the customer drips the proper amount of the indicator solution, an insufficient solution error is displayed and results cannot be obtained.
Additional Manufacturer Narrative
Initial reporter phone #: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
This complaint is confirmed.This complaint is for panel aborts due to insufficient indicator when using phoenix ast-s indicator (246009) batch 1243411.No product returns or photos were provided by the customer for investigation.Three bottles from retention were used to test 12 ast broths, and 12 internal qc panels.These panels were loaded into a phoenix instrument to observe for any test aborts at the end of the run.At the end of the run, there was one (1) test abort due to insufficient indicator.This complaint is confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints was performed and there were no additional complaints on this batch.Complaint trending was performed and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.Per baltrmphxidastaph rev 10 version h, id 15.0, a defective product obvious to user has a severity assessment of s1.
Event or Problem Description
It was reported that when using the bd phoenix¿ ast-s indicator solution, the proper reagent amount would not afford a reaction and insufficient, solution error would display.This is a report of a single occurrence.There were no results to report out to the clinician or to the patient.The following information was provided by the initial reporter: according to the customer's report, even though the customer drips the proper amount of the indicator solution, an insufficient solution error is displayed and results cannot be obtained.

• Brand Name: BD PHOENIX¿ AST-S INDICATOR SOLUTION
• Common Device Name: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14962328
• Report Number: 1119779-2022-00973
• Device Sequence Number: 20556833
• Product Code: LON
• UDI-Device Identifier: 30382902460092
• UDI-Public: 30382902460092
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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 Expiration Date: 06/30/2022
• Device Model Number: 246009
• Device Catalogue Number: 246009
• Device Lot Number: 1243411
• 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: 06/10/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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