MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR VX FACTOR; DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Model Number	231731
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	02/20/2023
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 bd bbl¿ taxo¿ differentiation discs for vx factor results of identification with taxo is discrepant with one by a mass spectrometry.No treatment was reported.The following information was provided by the initial reporter: report, the result of an identification with taxo is discrepant with the one by a mass spectrometry.
Additional Manufacturer Narrative
H.6 investigation summary: a complaint investigation due to discrepant results with taxo vx factors catalog 231731 batch no.: 2056559 was performed on retention samples.Returned goods were not received from customer.The investigation required to test product for performance, visual inspection, and batch record review.Retention samples performed as expected.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.Complaint is not confirmed.It is recommended to use microorganism stated on the product insert.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
Event or Problem Description
It was reported that bd bbl¿ taxo¿ differentiation discs for vx factor results of identification with taxo is discrepant with one by a mass spectrometry.No treatment was reported.The following information was provided by the initial reporter: report, the result of an identification with taxo is discrepant with the one by a mass spectrometry.

• Brand Name: BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR VX FACTOR
• Common Device Name: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16523898
• Report Number: 1024879-2023-00135
• Device Sequence Number: 2316262
• Product Code: JTO
• UDI-Device Identifier: 00382902317319
• UDI-Public: 00382902317319
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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: 09/30/2023
• Device Model Number: 231731
• Device Catalogue Number: 231731
• Device Lot Number: 2056559
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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