MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ TB FLUORESCENT STAIN KIT M; STAINS, MICROBIOLOGIC

Catalog Number	212519
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: this memo is to summarize findings on your complaint related to kit tb fluorescent stain kit m, catalog number 212519, batch number 3306430, complaint number (b)(4) for appearance.Components are mixed and blended (where required) and dispensed into containers.Following qc release, and based upon inventory demand, final packaging operations occur, which include dispensing into and labeling of final configurations, followed by transport to the distribution center.The complaint investigation included a review of the batch history record tb stain kit m.The batch history record review indicated no discrepancies.All release testing was satisfactory.Satisfactory appearance for auramine m component is ¿yellow suspension¿.By definition a suspension is ¿a mixture in which particles are dispersed throughout the bulk of the fluid¿.It is also defined as ¿a mixture in which all particles of a substance are dispersed throughout a gas or liquid.If a suspension is left undisturbed, the particles are likely to settle to the bottom.The particles in a suspension are larger than those in either a colloid or a solution¿.Complaint trends were reviewed for a period covering 12 months.During that time there have been no complaints for the defect in question for this product.Two photos and short video attached in a leu of return.The first photo depicts a bottle labeled with auramine m part number 212514 and lot number 3241141, expiration date 2024/08/31.The second photo depicts a bottle with yellow suspension with no visible label.The video shows the person inverting the bottle of auramine m (with yellow suspension) part number 212514, lot number 3241141, expiration date 2024/08/31.The retention sample from the complaint batch of tb stain kit m, tb auramine m component, was evaluated along with a control batch of tb auramine m for solution appearance.The solution appearance of the retention sample was comparable to the control and was a yellow suspension.This complaint is not confirmed.Bd will continue to trend on this issue.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.
Event or Problem Description
It was reported prior to using bd bbl¿ tb fluorescent stain kit m, there was white precipitate/sediment in the stain.There was no report of patient impact.

• Brand Name: BD BBL¿ TB FLUORESCENT STAIN KIT M
• Common Device Name: STAINS, MICROBIOLOGIC
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22938582
• Report Number: 1119779-2025-04791
• Device Sequence Number: 9676735
• Product Code: JTS
• UDI-Device Identifier: 00382902125198
• UDI-Public: (01)00382902125198(11)231102(17)240831(10)3306430
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 08/31/2024
• Device Catalogue Number: 212519
• Device Lot Number: 3306430
• 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: 05/03/2024
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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