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	09/24/2025
Type of Reportable Event	Malfunction
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.B3: date of event is unknown.The date received by manufacturer has been used for this field.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 that while using unspecified bd bbl¿ india ink reagent droppers, the customer noticed crystals are appearing in their slide readings.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: this memo summarizes the findings on your recent complaint (b)(4) on product 261194 (dropper india ink), lot number b03g155m.It was reported that the customer received an order of india ink to replace a previous shipment, which was reported for the presence of crystals, under another complaint.However, the same defective batch was sent to the customer, in which they can see the same crystals.Historical complaint data for sku 261194 shows no trend concerning the reported issue over the past year.A review of the batch history record (bhr) for the reported product and batch, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Also, the retain samples for reported product/batch were analyzed, and no anomalies were detected.No physical returns were available for analysis; however, the three accompanying photographs verify the presence of anomalies, which confirm the validity of the reported issue.Based on the investigation no definitive root cause could be determined.As no complaint trends are present at this time, no further action will be taken.Bd will continue to monitor trending for this issue.
Event or Problem Description
It was reported that while using unspecified bd bbl¿ india ink reagent droppers, the customer noticed crystals are appearing in their slide readings.There was no health impact or consequence reported.

• 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: 23304803
• Report Number: 1119779-2025-05141
• Device Sequence Number: 15959469
• Product Code: JTS
• UDI-Device Identifier: 30382902611944
• UDI-Public: (01)30382902611944(17)270131(10)B03G155M
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: B03G155M
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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