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

Model Number	246009
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	01/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd phoenix¿ ast-s indicator solution there was a performance issue - atypical growth, atypical reaction, failure to inhibit, insufficient growth, potency, ph failure for prepared reagents/media that could impact growth performance.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: there were "repeated failures on the bd strep panels 448785 when using strep indicator 246009.The reason on epicenter for the failure is insufficient indicator in the panel.Customer confirmed they are adding 1 full drop and keep the indicator refrigerated.".
Additional Manufacturer Narrative
H6: investigation summary: this complaint is for panel aborts due to insufficient indicator when using phoenix ast-s indicator (246009) batch 1145292 the customer did not provide lab reports, isolates, or panels for the investigation.The complaint batch was not available for investigation due to the batch being expired at the time of the investigation and is beyond our stability timeframe.As a result, this complaint is unconfirmed for performance.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed five additional complaints on 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 when using the bd phoenix¿ ast-s indicator solution there was a performance issue - atypical growth, atypical reaction, failure to inhibit, insufficient growth, potency, ph failure for prepared reagents/media that could impact growth performance.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: there were "repeated failures on the bd strep panels 448785 when using strep indicator 246009.The reason on epicenter for the failure is insufficient indicator in the panel.Customer confirmed they are adding 1 full drop and keep the indicator refrigerated.".

• Brand Name: BD PHOENIX¿ AST-S 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13545030
• Report Number: 1119779-2022-00247
• Device Sequence Number: 2174708
• Product Code: LON
• UDI-Device Identifier: 30382902460092
• UDI-Public: 30382902460092
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 12/05/2022

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: 03/31/2022
• Device Model Number: 246009
• Device Catalogue Number: 246009
• Device Lot Number: 1145292
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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