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

Catalog Number	212539
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	12/16/2025
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 after using one (1) bd bbl¿ gram stain kit, the customer noticed abnormal staining results.There were no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary- this memo is to summarize findings on the complaint related to kit gram stain stabilized, catalog number 212539, batch number 5056685, complaint # (b)(4) for unsatisfactory performance.Components are mixed and dispensed into the appropriate containers.After qc testing product is released and transported to the distribution center.The complaint investigation included a review of the gram stain kit.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 have been no confirmed complaints for the defect in question.Seven photos were received in a lieu of return.Three photos depict a microscopic view with a few gram-negative stained cultures.Two photos depict a microscopic view with part of the grid on the slide and a few artifacts.One of these two photos has a red marker circle on the grid.Two photos depict a person holding a glass slide with blue color squared grid and smears in square "c" and 9.Square 9 has red marker circle on it.A retention sample from the complaint batch number 5056685 was evaluated along with a control batch.Staining was completed per instructions in the product insert.Slides of e.Coli atcc 25922 and s.Aureus atcc 25923 controls were evaluated and had satisfactory staining results for the retention and control batches.The retention sample was comparable to the control.This complaint is not confirmed.Waters will continue to trend dcm complaints for unsatisfactory performance.
Event or Problem Description
It was reported after using one (1) bd bbl¿ gram stain kit, the customer noticed abnormal staining results.There were no health impact or consequences 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: 24020072
• Report Number: 1119779-2025-05548
• Device Sequence Number: 18380748
• Product Code: JTS
• UDI-Device Identifier: 00382902125396
• UDI-Public: (01)00382902125396(17)260731(10)5056685
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: 07/31/2026
• Device Catalogue Number: 212539
• Device Lot Number: 5056685
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2025
• 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