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	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported prior to using bd bbl¿ tb stain kit k, a kit component had an expiration date prior to kit expiration date.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: this memo is to summarize findings on the complaint related to kit tb stain kit k, catalog number 212522, batch number 4191205, complaint # 10910478 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-apr-2025 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.This mdr is being submitted as part of a retrospective review of records dating april 2023¿2025, under capa 11910483.

• 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: 22948624
• Report Number: 1119779-2025-04838
• Device Sequence Number: 18615427
• 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: NY
• 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
• Report Date (Section B): 07/14/2025

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: 10/03/2024
• Initial Report FDA Received Date: 09/02/2025
• 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