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

Catalog Number	212531
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	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bbl¿ gram safranin that there was precipitate in the stain, which appeared to be gram positive cocci.After multiple customer follow up attempts by bd there was no information provided regarding the occurrence.There was no health impact or consequence 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
Investigation summary - this memo is to summarize findings on your complaint related to bottle gram safranin 250ml, catalog number 212531, batch 5036602, and complaint #(b)(6) for solution appearance.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 safranin.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 complaints for the defect in question.No returns or photos were received.A retention sample from the complaint batch of gram safranin 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.Bd will continue to trend dcm complaints for solution appearance.
Event or Problem Description
It was reported while using bd bbl¿ gram safranin that there was precipitate in the stain, which appeared to be gram positive cocci.After multiple customer follow up attempts by bd there was no information provided regarding the occurrence.There was no health impact or consequence reported.

• Brand Name: BD BBL¿ GRAM SAFRANIN
• 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: 22915278
• Report Number: 1119779-2025-04537
• Device Sequence Number: 9055188
• Product Code: JTS
• UDI-Device Identifier: 30382902125311
• UDI-Public: (01)30382902125311(11)250205(17)260831(10)5036602
• 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): 12/01/2025

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: 08/31/2026
• Device Catalogue Number: 212531
• Device Lot Number: 5036602
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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