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

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

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

Event Date 10/28/2022

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 while using bd bbl¿ taxo¿ differentiation discs for vx factor insufficient growth occurred.The following information was provided by the initial reporter: " customer state h.Influenza did not grow when compared to hardy disc hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.".

Manufacturer Narrative

A complaint investigation due to low growth for taxo vx factor catalog 231731 batch no.: 2056559 was performed on retention samples.Returned goods received.Unable to tested.Packaging integrity was affected.Received not refrigerated, neither with ice pack.Photo received from customer was evaluated.Growth around hardy vx disc, light zone of growth around bbl disc and growth between v and x discs, presumptive growth of h.Influenzae.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.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.

Event Description

It was reported that while using bd bbl¿ taxo¿ differentiation discs for vx factor insufficient growth occurred.The following information was provided by the initial reporter: " customer state h.Influenza did not grow when compared to hardy disc hazard, injury or erroneous results? no.Hazard, injury or erroneous results details ".

• Brand Name: BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR VX 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15785700
• MDR Text Key: 305807931
• Report Number: 1024879-2022-00665
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 00382902317319
• UDI-Public: 00382902317319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2022
• 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: 231731
• Device Catalogue Number: 231731
• Device Lot Number: 2056559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• 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