MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX AP AST INDICATOR SOLUTION; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Model Number	246006
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: this complaint is for leaking phoenix ap ast indicator (246006) as well as a missing bottle label for batch 0352185.The customer provided photos for investigation.The photos showed indicator leakage on the outside of the bottle as well as a missing label on the one indicator bottle.Due to the photos provided, this complaint is confirmed for leakage and a missing label.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed no additional complaints on this batch.Complaint trending was performed and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.
Event or Problem Description
It was reported that while using bd phoenix¿ ap ast indicator solution missing label information was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "the customer found a bottle without a label that was also leaking upon unpacking.".

• Brand Name: BD PHOENIX AP AST INDICATOR SOLUTION
• Common Device Name: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 12436747
• Report Number: 1119779-2021-01481
• Device Sequence Number: 11657773
• Product Code: LON
• UDI-Device Identifier: 30382902460061
• UDI-Public: 30382902460061
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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: 01/31/2022
• Device Model Number: 246006
• Device Catalogue Number: 246006
• Device Lot Number: 0352185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1