MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ ID BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number	246001
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd phoenix¿ id broth, that 5 tubes contain impurities.This occurred with 5 tubes.No patient impact reported.The following information was provided by the initial reporter: "contains impurities.".
Additional Manufacturer Narrative
H.6.Investigation summary: this complaint is not confirmed.This complaint is for contamination of phoenix id broth tubes (246001) batch number 2312587.The customer provided a photo of the affected tubes but did not return samples for the investigation.The photos show multiple tubes with batch numbers present but defect could not be confirmed from the photos.To investigate, retention samples of the complaint batch were manually and visually inspected for impurities.The inspection revealed no tubes with impurities, this complaint is not confirmed.A review of quality notifications reviewed no quality notifications generated on the complaint batch.A review of complaints revealed no other complaints on batch 2312587.Complaint trending was performed and there are no trends associated with this defect.Bd id/ast will continue to monitor for trends associated with this defect and take action as necessary.H3 other text : see h.10.

• Brand Name: BD PHOENIX¿ ID BROTH
• Common Device Name: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17439918
• Report Number: 1119779-2023-00821
• Device Sequence Number: 16821894
• Product Code: JSG
• UDI-Device Identifier: 30382902460016
• UDI-Public: 30382902460016
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• 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): 07/28/2023

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: 11/04/2023
• Device Catalogue Number: 246001
• Device Lot Number: 2312587
• 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: 07/13/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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