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	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using one (1) bd bbl¿ gram stain kit, there was precipitate present affecting the user's ability to distinguish precipitate from organism.There was no health impact or consequence reported.
Additional Manufacturer Narrative
D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.D4.Medical device lot#: unknown.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 the complaint related to kit gram stain stabilized, catalog number 212539, batch number unknown, complaint # (b)(4) for solution appearance.Components are mixed and dispensed into the appropriate containers.After qc testing product is released and transported to the distribution center.A review of the batch history record could not be completed as no lot number was provided.The complaint trends were reviewed for a period covering 12 months.During that time, there have been no trends for this product.No returns or photos were provided.Unable to test retentions as no batch number was provided.The customer reported there was a precipitate in the product.This complaint cannot be confirmed based on the information provided.Waters will continue to trend on performance complaints and assess product intended uses against regulatory requirements.
Event or Problem Description
It was reported while using one (1) bd bbl¿ gram stain kit, there was precipitate present affecting the user's ability to distinguish precipitate from organism.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: 24002477
• Report Number: 1119779-2025-05547
• Device Sequence Number: 21465308
• Product Code: JTS
• UDI-Device Identifier: 00382902125396
• UDI-Public: (01)00382902125396
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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 Catalogue Number: 212539
• Device Lot Number: UNKNOWN
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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