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

Model Number	246004
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
Event or Problem Description
It was reported when using the bd phoenix¿ ast 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.The following information was provided by the initial reporter.The customer stated: there was "an error in which the color has faded and would like to know if this issue occurred at other facilities with the same lot, the cause of the indicator solution error, and if there is some way to prevent this error.".
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 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.The following information was provided by the initial reporter.The customer stated: there was "an error in which the color has faded and would like to know if this issue occurred at other facilities with the same lot, the cause of the indicator solution error, and if there is some way to prevent this error.".
Additional Manufacturer Narrative
H.6 investigation summary: this complaint is for panel aborts due to insufficient indicator when using phoenix ast indicator (246004) batch 1187121.The customer did not provide photos or returns for investigation.Three bottles from retention were used to test 12 ast broths, and 12 internal qc panels.These panels were loaded into a phoenix instrument to observe for any test aborts at the end of the run.At the end of the run, there were no test aborts due to insufficient indicator.This complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints was performed and there was one additional complaint on this batch not related to this defect.Complaint trending was performed and no trends were identified associated with this defect.

• Brand Name: BD PHOENIX¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13545933
• Report Number: 1119779-2022-00250
• Device Sequence Number: 5215736
• Product Code: LON
• UDI-Device Identifier: 30382902460047
• UDI-Public: 30382902460047
• 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): 07/12/2022

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: 07/31/2022
• Device Model Number: 246004
• Device Catalogue Number: 246004
• Device Lot Number: 1187121
• 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: 07/12/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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