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	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter phone #: (b)(6).Investigation summary: this complaint is not confirmed.This complaint is for foreign matter in phoenix ast broth (246003) batch number 2300287.The customer provided photos but did not provide product returns for the investigation.The photos show a phoenix ast broth with foreign matter resembling mold inside but batch number was not present in the photos.To investigate, retention bottles of complaint batch 2300287 was manually and visually inspected for foreign matter.The inspection returned no bottles with foreign matter within.Therefore, this complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints was performed and revealed no additional complaints on the complaint batch.Complaint trending was performed and no trends were identified associated with this defect.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.
Event or Problem Description
It was reported while using bd phoenix¿ ast broth, a tube was contaminated.There was no report of patient impact.

• 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: 22931443
• Report Number: 1119779-2025-04661
• Device Sequence Number: 10390452
• Product Code: LON
• UDI-Device Identifier: 30382902460030
• UDI-Public: (01)30382902460030(11)221027(17)231024(10)2300287
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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: 10/24/2023
• Device Catalogue Number: 246003
• Device Lot Number: 2300287
• 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: 08/31/2023
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2022
• 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