MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ CALCOFLUOR WHITE REAGENT DROPPER; STAINS, MICROBIOLOGIC

Catalog Number	261195
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bbl¿ calcofluor white reagent dropper, an unspecified number of droppers were contaminated.There was no report of patient impact.
Additional Manufacturer Narrative
"investigation summary: this memo serves to summarize findings on your recent complaint 7534886 on product 261194 (dropper calcofluor white), lot numbers b02e299m and b02e347m, where it was observed that the reagent was contaminated with hyphae.Event description: "" customer states the product is contaminated."" complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: a review of the device history record does not indicate any manufacturing issues.Sample analysis: no photos or returns were available.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, no defect was observed.An inspection of the returns provided did not show any defect with the ampoule.There is no systemic failure in the manufacturing process and the retention samples were satisfactory.No complaint trend exists on this issue with this product.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.As no deviations were observed in the investigation, no corrective or preventive actions are indicated at this time.However, bd will continue to monitor for trending." this mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.

• Brand Name: BD BBL¿ CALCOFLUOR WHITE REAGENT DROPPER
• 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: 22574686
• Report Number: 1119779-2025-01800
• Device Sequence Number: 13129996
• Product Code: JTS
• UDI-Device Identifier: 30382902611951
• UDI-Public: (01)30382902611951(11)221222(17)240424(10)B02E347M
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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: 04/24/2024
• Device Catalogue Number: 261195
• Device Lot Number: B02E347M
• 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: 03/24/2023
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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