MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ TB AURAMINE M; AURAMINE O

Catalog Number	212514
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	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using one (1) bd bbl¿ tb auramine m bottle, there was precipitation present in the stain.There was no health impact or consequence reported.
Additional Manufacturer Narrative
E1.Initial reporter phone #: (b)(6).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 while using one (1) bd bbl¿ tb auramine m bottle, there was precipitation present in the stain.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary - introduction this memo is to summarize findings on your complaint related to bottle tb auramine m 250ml, catalog number 212514, batch number 5189943, complaint # (b)(4) for solution appearance defect.Background components are mixed and dispensed into the appropriate containers.After qc testing product is released and transported to the distribution center.Batch history review the batch history record review indicated no discrepancies.Complaint history review the complaint trends were reviewed for a period covering 12 months.During that time there have been no other confirmed complaints for these issues.Returned material analysis no photos or returns were available at the time of the investigation.Investigational testing/review all release testing was satisfactory.Satisfactory appearance 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¿.The retention sample from the complaint batch number 5189943 was evaluated along with a control batch of tb auramine m.There was a large amount of particulate visible in the retention samples as well as the control.Staining was completed per instructions in the product insert.Slides of positive (m.Tuberculosis atcc 25177) and negative (b.Subtilis atcc 6533) controls were evaluated and gave satisfactory staining results with the retention and control batches.The retention sample was comparable to the control.Conclusion: this complaint cannot be confirmed.Bd will continue to trend solution appearance complaints and assess product intended uses against regulatory requirements.

• Brand Name: BD BBL¿ TB AURAMINE M
• Common Device Name: AURAMINE O
• 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: 24896189
• Report Number: 1119779-2026-00676
• Device Sequence Number: 18621590
• Product Code: KJK
• UDI-Device Identifier: 30382902125144
• UDI-Public: (01)30382902125144(17)260630(10)5189943
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 06/30/2026
• Device Catalogue Number: 212514
• Device Lot Number: 5189943
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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