MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AST INDICATOR SOLUTION; SEE H.10

Model Number	246004
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: system, test, automated antimicrobial susceptibility, short incubation.Investigation summary this complaint is confirmed.This complaint is for leaking phoenix ast indicator (246004) batch number 2116524.The customer did not provide sample returns, but photos were provided for investigation.The photos showed indicator in the pouch and on the bottle.Based on the photos provided, 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 two (2) additional complaints on this batch.Complaint trending was performed and a complaint trend was identified for this defect.Based on the severity and rate, a corrective and preventive action (capa) investigation has been initiated for this defect.Bd id/ast plant quality will continue to closely monitor trends for this defect, including changes in severity and rate.
Event or Problem Description
It was reported that while using the bd phoenix¿ ast indicator solution that there was a leaking bottle.The following information was provided by the initial reporter: indicator vial was leaked, indicator solution has spilled outside of vial when customer opened pouch.

• Brand Name: BD PHOENIX¿ AST INDICATOR SOLUTION
• Common Device Name: SEE H.10
• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16475504
• Report Number: 1119779-2023-00197
• Device Sequence Number: 17973225
• Product Code: LON
• UDI-Device Identifier: 30382902460047
• UDI-Public: 30382902460047
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

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: 05/31/2023
• Device Model Number: 246004
• Device Catalogue Number: 246004
• Device Lot Number: 2116524
• 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: 02/16/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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