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	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported before use of bd bbl tb auramine m, precipitation/yellow pigment was observed at the bottom of the bottle.There was no health impact or consequences reported.
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.
Additional Manufacturer Narrative
Investigation summary: this memo is to summarize findings on your complaint related to bottle tb auramine m 250ml, catalog number 212514, batch# 3241141 and complaint #(b)(4).For appearance.Components are mixed 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 auramine m.The batch history record review indicated no discrepancies.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¿.Complaint trends were reviewed for a period covering 12 months.During that time there have been no confirmed complaints for the defect in question for this product.Three photos were attached to the complaint.The first photo depicts one bottle with yellow solution and label for tb auramine m part # 212514 and lot # 3241141, expiration date 2024/0/31.The second photo depicts the bottom of the bottle with yellow suspension.The third photo depicts the bottle tilted down and away from the camera with particles stuck to the bottom of the bottle.The retention sample from the complaint batch 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.The retention sample was comparable to the control.The precipitate in question is inherent to the stain and does not affect the performance of the stain.The complaint is not confirmed.Bd will continue to trend on this issue.If you have further questions, please contact technical services.
Event or Problem Description
It was reported before use of bd bbl tb auramine m, precipitation/yellow pigment was observed at the bottom of the bottle.There was no health impact or consequences reported.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19975506
• Report Number: 1119779-2024-00594
• Device Sequence Number: 7057428
• Product Code: KJK
• UDI-Device Identifier: 00382902125143
• UDI-Public: (01)00382902125143(11)230829(17)240831(10)3241141
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 01/08/2025

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: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 212514
• Device Lot Number: 3241141
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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