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	08/02/2021
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 while using bd phoenix¿ ap ast indicator solution incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "this is a report about a label issue.".
Additional Manufacturer Narrative
H.6.Investigation: this complaint is for discrepant labeling in the barcode when using phoenix ap ast indicator (246006) batch 1123316.The customer did provide photos for investigation.It showed the material number 246004 in the barcode where it should have read 246006.Based on the photo provided this complaint is confirmed.A review of quality notifications revealed one quality notification for the complaint batch that is related to this issue.A review of complaints revealed no additional complaints for the complaint 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 incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "this is a report about a label issue.".

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12356804
• Report Number: 1119779-2021-01421
• Device Sequence Number: 17226737
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 05/31/2022
• Device Model Number: 246006
• Device Catalogue Number: 246006
• Device Lot Number: 1123316
• 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: 08/02/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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