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

Model Number 231727

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2023

Event Type  malfunction  

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 Description

It was reported that bd bbl¿ taxo¿ differentiation discs for v factor result of identification with taxo is discrepant with one by mass spectrometry.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.

Event Description

It was reported that bd bbl¿ taxo¿ differentiation discs for v factor result of identification with taxo is discrepant with one by mass spectrometry.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.

Manufacturer Narrative

H.6 investigation summary: a complaint investigation due to discrepant results with taxo v factors catalog 231727 batch no.: 2056541 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.H3 other text : see h.10.

• Brand Name: BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR V FACTOR
• Type of Device: 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: 16552080
• MDR Text Key: 311390877
• Report Number: 1024879-2023-00143
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 00382902317272
• UDI-Public: (01)00382902317272
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 231727
• Device Catalogue Number: 231727
• Device Lot Number: 2056541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1