MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ INDIA INK REAGENT DROPPERS; STAINS, MICROBIOLOGIC

Catalog Number	261194
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	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bbl¿ india ink reagent droppers that one ampule had grainy and unusable stain.There was no health impact or consequence reported.
Additional Manufacturer Narrative
The manufacturing location for this product is rr donnelley.This site is an oem manufacturing site.Therefore, bd corporate headquarters in sparks, md has been listed in sections d.3.And g.1.And the sparks fda registration number has been used for the manufacture report number.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd bbl¿ india ink reagent droppers that one ampule had grainy and unusable stain.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary - event description: "the customer reported that product was unusable because it is filled with refractive artifacts that make it impossible to read the slides under a microscope." complaint history review: a review of past complaints for 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 provided.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, no defect was observed.The retention samples were satisfactory.No complaint trend exists.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.As no complaint trends are present at this time, no further action will be taken.Bd will continue to monitor trending.

• Brand Name: BD BBL¿ INDIA INK REAGENT DROPPERS
• 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: 22649050
• Report Number: 1119779-2025-02039
• Device Sequence Number: 18295099
• Product Code: JTS
• UDI-Device Identifier: 30382902611944
• UDI-Public: (01)30382902611944(11)240613(17)270131(10)B02G149M
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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 Catalogue Number: 261194
• Device Lot Number: B02G149M
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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