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

Catalog Number	212522
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported prior to using bd bbl¿ tb stain kit k that one bottle of tb carbolfushin had an expiration date prior to the kit expiration.There was no health impact or consequence 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.
Event or Problem Description
It was reported prior to using bd bbl¿ tb stain kit k that one bottle of tb carbolfushin had an expiration date prior to the kit expiration.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: this memo is to summarize findings on your complaint related to kit tb stain kit k, catalog number 212522, batch number 4191205, complaint # (b)(4) for unsatisfactory packaging.Components are mixed and dispensed into the appropriate containers.After qc testing product is released and transported to the distribution center.The batch history record review indicated no discrepancies.All release testing was satisfactory.Complaint trends were reviewed for a period covering 12 months.During that time there has been a trend for this defect identified.The customer reported the kit expiration date is 30-apr2025 but a component within the kit expires 30-sep-2024.This complaint is confirmed based on customer photos and retained kits.A corrective and preventative action (capa) was initiated for the defect in question.Bd will continue to trend on labeling complaints and assess product intended uses against regulatory requirements.If you have further questions, please contact bd technical services.

• Brand Name: BD BBL¿ TB STAIN KIT K
• 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: 21876782
• Report Number: 1119779-2025-00287
• Device Sequence Number: 7899781
• Product Code: JTS
• UDI-Device Identifier: 00382902125228
• UDI-Public: (01)00382902125228(11)240709(17)250430(10)4191205
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 04/30/2025
• Device Catalogue Number: 212522
• Device Lot Number: 4191205
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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