MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST; DNA PROBE, YEAST

Model Number	446252
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	07/21/2022
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 by the customer that - issue with qc.Bd affirm¿ vpiii microbial identification test which also affected three patient samples.Repeat testing was performed.No patient impact was reported.The following information was provided by the initial reporter: "we have a half of box that we are throwing and affected 3 patients.".
Additional Manufacturer Narrative
H.6 investigation summary: quality initiated an investigation on qc failure.Some samples were all positive and some were all negative.Batch history record review was performed to the finished product and its components, no deviation was reported on any record.In-process and qc testing were within specifications.Visual inspection was performed to the retention sample and returned good sample with satisfactory results.Functional test was performed to the retention and returned good sample with satisfactory results.Bd cayey will continue to closely monitor for trends associated with qc failure.Complaint unconfirmed based on retention and returned goods samples and batch history records review.H3 other text : see h.10.
Event or Problem Description
It was reported by the customer that issue with qc.Bd affirm¿ vpiii microbial identification test which also affected three patient samples.Repeat testing was performed.No patient impact was reported.The following information was provided by the initial reporter: "we have a half of box that we are throwing and affected 3 patients".

• Brand Name: BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST
• Common Device Name: DNA PROBE, 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: 15255046
• Report Number: 1119779-2022-01131
• Device Sequence Number: 5812013
• Product Code: MLA
• UDI-Device Identifier: 00382904462529
• UDI-Public: 00382904462529
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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: 01/18/2023
• Device Model Number: 446252
• Device Catalogue Number: 446252
• Device Lot Number: 2088202
• 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: 07/21/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• 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