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	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device lot #: 1088556 was reported, however, this is not a lot# manufactured for this product.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that while testing patient samples with bd phoenix¿ ast-s indicator solution there were many failures in smic galleries.Confirmatory testing was done using agar plates.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: we have had many failures of our smic galleries.I incriminated the reagent ref 246009.Having a new batch we did our antibiotic susceptibility tests with it and no more failures.
Additional Manufacturer Narrative
H.6 investigation summary: this complaint is for panel aborts due to insufficient indicator when using phoenix ast-s indicator ((b)(4).) batch 1088556.The customer did not provide returns, photos or lab reports for the investigation.The complaint batch 1088556 was not available for investigation due to the batch being expired at the time of the investigation and is beyond our stability timeframe.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed no additional complaints on the complaint batch.Based on the investigation performed, this complaint is unable to be confirmed.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 testing patient samples with bd phoenix¿ ast-s indicator solution there were many failures in smic galleries.Confirmatory testing was done using agar plates.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: we have had many failures of our smic galleries.I incriminated the reagent ref (b)(4).Having a new batch we did our antibiotic susceptibility tests with it and no more failures.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12591609
• Report Number: 1119779-2021-01616
• Device Sequence Number: 19910146
• Product Code: LON
• UDI-Device Identifier: 30382902460092
• UDI-Public: 30382902460092
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/06/2022

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 Model Number: 246009
• Device Catalogue Number: 246009
• Device Lot Number: SEE H10
• 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: 09/09/2021
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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