MAUDE Adverse Event Report: TRIPATH IMAGING, INC 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	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd phoenix¿ ast broth an unspecified number of broths were contaminated and had liquid volume level failures.The user noted using the contaminated broths stating, "there are several antibiotics that failed.A few examples are ciprofloxacin, sxt, penicillin, ampicillin, etc." the user performed repeat testing using a reference laboratory.No health impact or consequence reported.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: the customer complaint is for contamination in one (1) tube of material 246003 lot number 5260860, tube phoenix ast broth sp100.Material 246003 is produced at the bd mebane, nc facility on an automated filling line and manually packed.Production of 246003 lot 5260860 started on 17sep2025.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 that could contribute to the failure mode.A retain analysis was performed and there were no tubes found with any growth.Additional microbial load testing was performed.Results from the test revealed no growth, no turbidity, providing a reasonable assurance that the product is free from viable organisms.A photograph was provided.The picture shows tubes with contamination in the liquid before use.Therefore, the complaint is confirmed.Bd apologizes for the inconvenience caused by the issue.Monthly complaint trending through february 2025, 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.
Event or Problem Description
It was reported while using the bd phoenix¿ ast broth an unspecified number of broths were contaminated and had liquid volume level failures.The user noted using the contaminated broths stating, "there are several antibiotics that failed.A few examples are ciprofloxacin, sxt, penicillin, ampicillin, etc." the user performed repeat testing using a reference laboratory.No health impact or consequence reported.

• Brand Name: BD PHOENIX¿ AST BROTH
• Common Device Name: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): TRIPATH IMAGING, INC; 1022 corporate park drive; mebane NC 27302
• Manufacturer (Section G): TRIPATH IMAGING, INC; 1022 corporate park drive; mebane NC 27302
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 24268747
• Report Number: 3008007472-2026-00001
• Device Sequence Number: 10022028
• Product Code: LON
• UDI-Device Identifier: 30382902460030
• UDI-Public: (01)30382902460030(17)260904(10)5260860
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/19/2026

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: 09/04/2026
• Device Catalogue Number: 246003
• Device Lot Number: 5260860
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2025
• 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