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

Model Number	246001
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	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd phoenix¿ id broth tube was seen with contamination.The following information was provided by the initial reporter: when customer use id broth tube to id/ast test, they saw the broth in tube was contaminated.
Additional Manufacturer Narrative
H.6 investigation summary: this complaint is for foreign matter in tubes of phoenix id broth (246001) batch number 2174602.The customer did not provide product returns for investigation but provided photos.The photos show phoenix broth tubes with batch number present and contamination visible in the photo.As a result of the photos, this complaint is confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.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.Please continue to communicate additional concerns.
Event or Problem Description
It was reported that bd phoenix¿ id broth tube was seen with contamination.The following information was provided by the initial reporter: when customer use id broth tube to id/ast test, they saw the broth in tube was contaminated.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16577422
• Report Number: 1119779-2023-00299
• Device Sequence Number: 4697158
• Product Code: JSG
• UDI-Device Identifier: 30382902460016
• UDI-Public: 30382902460016
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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: 06/16/2023
• Device Model Number: 246001
• Device Catalogue Number: 246001
• Device Lot Number: 2174602
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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