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

Catalog Number	246003
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	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter e-mail: (b)(6).H3.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 while using the bd phoenix¿ ast broth biological contamination is noted within the broth.No health impact or consequence reported.This is report 9 of 18.
Event or Problem Description
It was reported while using the bd phoenix¿ ast broth biological contamination is noted within the broth.No health impact or consequence reported.This is report 9 of 18.
Additional Manufacturer Narrative
Investigation summary: the customer complaint is for contamination of eighteen (18) 246003 lot number 5148710, tube phoenix ast broth (b)(4) ea.Material 246003 is produced on an automated filling line and manually packed in the kitting cell.Production of 246003 lot 5148710 started on 09jun2025 at the bd mebane, nc production facility.The review of the manufacturing dhr for the lot number identified that it was complete and accurate with no indication of abnormal problems during manufacturing.All qc testing met the acceptance criteria for performance and functional testing and did not have any contaminated media observed.A retain analysis was performed and there were no tubes found with any growth.Pictures were provided that show contamination in multiple tubes of broth, the complaint is confirmed.Bd apologizes for the inconvenience caused by the issue.Monthly complaint trending through march 2026 when the complaint was received, using 18 months of data, identified prior complaints related to this defect mode.Bd has a corrective and preventative action (capa) open for phoenix broth contamination complaints and is currently in implementation phase.The investigation has identified the issue to be intermittent tube and cap sealing issues, resulting in individual tubes becoming contaminated.Multiple actions are being implemented to address the intermittent seal integrity issues.Following visual inspection of the tubes, any tubes exhibiting visible contamination or a compromised seal should be discarded; however, as the contamination is not pervasive across the entire lot, broth batches that have passed user qc and tubes exhibiting no growth or turbidity may be used.Bd apologizes for the inconvenience caused by the issue.

• Brand Name: BD PHOENIX¿ AST BROTH
• 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 ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 24913302
• Report Number: 3008007472-2026-00011
• Device Sequence Number: 21107830
• Product Code: LON
• UDI-Device Identifier: 30382902460115
• UDI-Public: (01)30382902460115(10)5148710
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 05/21/2026
• Device Catalogue Number: 246003
• Device Lot Number: 5148710
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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