MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AST-S BROTH; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Model Number	246007
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event is unknown.The date received by manufacturer has been used for this field.Investigation summary: this complaint is not confirmed.This complaint is for missing labels of phoenix ast-s broth (246007) batch number 2362112.The customer provided photos for investigation, but no product returns.The photos show a carton of ast-s broth with batch number present.Another photo shows two tubes with no labels present.Further investigation of retention samples revealed no tubes with missing labels.As a result, this complaint is not confirmed.A review of quality notifications revealed no quality notification 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.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 prior to use of bd phoenix¿ ast-s broth, there were two tubes without labels.There was no patient impact reported.The following information was provided by the initial reporter: "tubes without any labels.".

• Brand Name: BD PHOENIX¿ AST-S 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17204732
• Report Number: 1119779-2023-00706
• Device Sequence Number: 6799170
• Product Code: LON
• UDI-Device Identifier: 30382902460078
• UDI-Public: 30382902460078
• Combination Product (Y/N): N
• Initial Reporter Country: BA
• PMA/510(K) Number: K050745
• 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): 06/23/2023

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: 07/10/2023
• Device Model Number: 246007
• Device Catalogue Number: 246007
• Device Lot Number: 2362112
• 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: 06/08/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• 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