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	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd phoenix¿ ast broth, a tube was contaminated with mold.There was no report of patient impact.
Additional Manufacturer Narrative
E.1 initial reporter e-mail: (b)(6).H.6 investigation summary: this complaint is for foreign material resembling mold in a tube of phoenix ast broth (246003) batch number 2335911.The customer provided photos for investigation, however no product returns.The photos illustrated a tube of broth with discoloration resembling mold with batch number present.As a result of the photos, this complaint is confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints was performed and revealed three additional complaints on the complaint batch, related to this defect and confirmed.Complaint trending was performed and no trends were identified associated with this defect.A bd id/ast plant quality will continue to monitor for trends associated with this defect.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.

• 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: 22912693
• Report Number: 1119779-2025-04519
• Device Sequence Number: 15715337
• Product Code: LON
• UDI-Device Identifier: 30382902460030
• UDI-Public: (01)30382902460030(11)221201(17)231201(10)2335911
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 07/09/2025

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: 12/01/2023
• Device Catalogue Number: 246003
• Device Lot Number: 2335911
• 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: 08/24/2023
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2022
• 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