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

Catalog Number	212525
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	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using one bottle of bd bbl¿ gram crystal violet, there was false positive gram stain results due to staining precipitate left over on the slides.No patient or user impact reported.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
This memo is to summarize findings on your complaint related to bottle gram crystal violet 250ml, catalog number 212525, batch 4233118 and complaint # (b)(4) for performance issue.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 batch history review of the gram crystal violet.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 for this product.Four photos were received in a leu of return.One photo depicts the label of gram crystal violet with date opened 7/12/25.Three other pictures depict the label of crystal violet bottle lot number 4233118, expiration date 2026-03-31.A retention sample from the complaint batch was evaluated along with a control batch of crystal violet.The solution appearance of retention sample was satisfactory and comparable to the control; all were deep purple solution with no visible precipitate.Slides of e.Coli atcc 25922 and s.Aureus atcc 25923 controls were evaluated and had satisfactory staining results for retention and control batches.Ten fields of each smear were examined in detail using oil immersion lens of a light microscope.No excessive precipitate, artifacts or bacterial contamination were seen.The retention sample was comparable to the control.This complaint cannot be confirmed.Bd will continue to trend performance complaints on dcm products.
Event or Problem Description
It was reported while using one bottle of bd bbl¿ gram crystal violet, there was false positive gram stain results due to staining precipitate left over on the slides.No patient or user impact reported.

• Brand Name: BD BBL¿ GRAM CRYSTAL VIOLET
• 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: 22771284
• Report Number: 1119779-2025-02891
• Device Sequence Number: 15744978
• Product Code: JTS
• UDI-Device Identifier: 30382902125250
• UDI-Public: (01)30382902125250(11)240820(17)260331(10)4233118
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 10/06/2025

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: 03/31/2026
• Device Catalogue Number: 212525
• Device Lot Number: 4233118
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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