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

Catalog Number	246004
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during use of bd phoenix¿ ast indicator solution, a test abort due to insufficient indicator occurred and the customer believes the product was mislabeled.There was no health impact or consequences reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 18-dec-2024.Investigation summary: this complaint is for insufficient indicator test aborts due to color variation when using phoenix ast indicator (catalog number 246004) batch number 4059590.The customer did not provide phoenix generated lab reports but provided indicator returns and photos for the investigation.The photos show the indicator bottle with batch number present.The customer returned product was not temperature controlled during shipping and not used in complaint investigation.For investigation, three retention samples of phoenix ast indicator from the complaint batch were dropped into ast broth tubes and then poured into internal qc panels.The qc panels were ran on a m50 instrument to observe for test aborts.At the end of the run, there were no test aborts observed due to insufficient indicator or color variation.Therefore, this complaint is not confirmed for a performance issue.A review of quality notifications revealed no quality notifications generated on the complaint batch complaint trending was performed, and no trends were identified associated with this defect.
Event or Problem Description
It was reported during use of bd phoenix¿ ast indicator solution, a test abort due to insufficient indicator occurred and the customer believes the product was mislabeled.There was no health impact or consequences reported.

• Brand Name: BD PHOENIX¿ AST 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: matt j. connor_old ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20779941
• Report Number: 1119779-2024-00927
• Device Sequence Number: 9033081
• Product Code: LON
• UDI-Device Identifier: 30382902460047
• UDI-Public: (01)30382902460047(11)240228(17)250227(10)4059590
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 02/27/2025
• Device Catalogue Number: 246004
• Device Lot Number: 4059590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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