MAUDE Adverse Event Report: TRIPATH IMAGING, INC BD PHOENIX AST BROTH 4.5 ML; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	246011
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd phoenix ast broth 4.5 ml a patient sample had an invalid result due to the product being mix with another within the shelf packaging.All of the patient testing needed to be repeated.No health impact or consequence reported.Report 11 of 21.
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: this complaint is for mixed components of phoenix ast broth tubes (catalog number 246011) batch number 4165109.The customer did not provide returns but provided a photo for the investigation.The photo shows a phoenix ast broth carton with batch number present, with two different tubes within.This complaint is confirmed.The batch history record was satisfactory, and no quality notifications were generated during manufacturing and inspection.Complaint trending was performed, and no trends were identified associated with this defect.Bd will continue to monitor for trends and take action as necessary.
Event or Problem Description
It was reported while using the bd phoenix ast broth 4.5 ml a patient sample had an invalid result due to the product being mix with another within the shelf packaging.All of the patient testing needed to be repeated.No health impact or consequence reported.Report 11 of 21.

• Brand Name: BD PHOENIX AST BROTH 4.5 ML
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20516937
• Report Number: 3008007472-2024-00023
• Device Sequence Number: 8724801
• Product Code: LON
• UDI-Device Identifier: 30382902460115
• UDI-Public: (01)30382902460115(11)240613(17)250604(10)4165109
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 06/04/2025
• Device Catalogue Number: 246011
• Device Lot Number: 4165109
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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