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	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Report 2 of 2: 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 d3 and g1 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
Report 2 of 2: 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 - bd had not received samples or photos for investigation.Therefore, retention samples were visually examined, and no issues were observed relating to precipitate as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode of precipitate.A root cause was unable to be identified.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 22203369
• Report Number: 1119779-2025-00586
• Device Sequence Number: 7714569
• Product Code: JTS
• UDI-Device Identifier: 30382902611944
• UDI-Public: (01)30382902611944(11)250114(17)270831(10)B01H006M
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: B01H006M
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2025
• 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