MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ YEAST ID; KIT, IDENTIFICATION, YEAST

Model Number	448316
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	10/10/2022
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 the bd phoenix¿ yeast id there was an increase in aborted panels with message ¿one or more fluorescent wells are out of range¿.The id portion of the panel has been completed and the isolate should be retested.No patient impact was reported.The following information was provided by the initial reporter: continued and increasing evidence of phoenix yeast panels aborted by special message ¿one or more fluorescent wells are out of range¿ the id portion of the panel has been completed and the isolate should be retested.Lot 2060322 expiration date: 2023-03-31.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2022-01319 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that while using the bd phoenix¿ yeast id there was an increase in aborted panels with message ¿one or more fluorescent wells are out of range¿.The id portion of the panel has been completed and the isolate should be retested.No patient impact was reported.The following information was provided by the initial reporter: continued and increasing evidence of phoenix yeast panels aborted by special message ¿one or more fluorescent wells are out of range¿ the id portion of the panel has been completed and the isolate should be retested.Lot 2060322.Expiration date: 2023-03-31.

• Brand Name: BD PHOENIX¿ YEAST ID
• Common Device Name: KIT, IDENTIFICATION, YEAST
• 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: 15645677
• Report Number: 1119779-2022-01319
• Device Sequence Number: 14961513
• Product Code: JXB
• UDI-Device Identifier: 30382904483167
• UDI-Public: 30382904483167
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• 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): 12/15/2022

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: 03/31/2023
• Device Model Number: 448316
• Device Catalogue Number: 448316
• Device Lot Number: 2060322
• 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: 10/10/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• 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