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

Model Number	261195
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	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd bbl¿ calcofluor white reagent dropper product is contaminated.The following information was provided by the initial reporter: customer states the product is contaminated.We noticed 70% contamination and was detected with hyphae present on neg cal.W slide (e.Coli + koh+cal.W).
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4: medical device lot#: b02e299m, d4: medical device expiration date: 30-nov-2023, h4: device manufacture date:04-nov-2022.D4: medical device lot#: b02e347m, d4: medical device expiration date: 24-apr-2024, h4: device manufacture date: 22-dec-2022.H3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary this memo serves to summarize findings on your recent complaint (b)(4) 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.
Event or Problem Description
It was reported that bd bbl¿ calcofluor white reagent dropper product is contaminated.The following information was provided by the initial reporter: customer states the product is contaminated.We noticed 70% contamination and was detected with hyphae present on neg cal.W slide (e.Coli + koh+cal.W).
Additional Manufacturer Narrative
The following updates have been made: this mdr pertains only to lot number b02e299m.B5.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.This supplemental mdr is being submitted as part of a retrospective review of records dating april 2023¿2025, under capa 11910483.
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.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16744969
• Report Number: 1119779-2023-00422
• Device Sequence Number: 6446205
• Product Code: JTS
• UDI-Device Identifier: 30382902611951
• UDI-Public: 30382902611951
• 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,Followup,Followup
• Report Date (Section B): 08/14/2025

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 Model Number: 261195
• Device Catalogue Number: 261195
• 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
• Supplement Date Received by Manufacturer: 08/18/2023; 08/14/2025
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 08/22/2023; 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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