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

Catalog Number	212539
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 prior to using bd bbl¿ gram stain kit that one (1) case was missing the product label.The contents of the case were labeled appropriately.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: 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 not been a trend for this defect.The customer reported the label on the kit box was missing.No photos or returns were provided.This complaint cannot be confirmed.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.
Event or Problem Description
It was reported prior to using bd bbl¿ gram stain kit that one (1) case was missing the product label.The contents of the case were labeled appropriately.There was no health impact or consequence reported.

• Brand Name: BD BBL¿ GRAM STAIN KIT
• 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: 21665552
• Report Number: 1119779-2025-00206
• Device Sequence Number: 20772398
• Product Code: JTS
• UDI-Device Identifier: 00382902125396
• UDI-Public: (01)00382902125396(11)241209(17)260531(10)4344672
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/04/2025

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: 05/31/2026
• Device Catalogue Number: 212539
• Device Lot Number: 4344672
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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