MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ DMACA INDOLE REAGENT DROPPER; SEE H11

Catalog Number	261187
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but photos were provided for investigation.The photos were reviewed and the indicated failure mode for a broken ampule was observed.A small glass shard was visible poking through the plastic container and product label.The contents of the ampule appear to have leaked onto the label around the glass shard.Additionally, retention samples were visually examined, and no issues were observed.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 has been confirmed for the indicated failure mode of broken glass ampule.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.
Event or Problem Description
It was reported while using bd bbl¿ dmaca indole reagent dropper, the bottle broke, causing a cut and exposing the user to the reagent.There was no report of adverse impact or medical intervention.
Event or Problem Description
It was reported while using bd bbl¿ dmaca indole reagent dropper, the bottle broke, causing a cut and exposing the user to the reagent.There was no report of adverse impact or medical intervention.
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.D2.Common device name: discs, strips and reagents, microorganism differentiation e1.(b)(6) hospital.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD BBL¿ DMACA INDOLE REAGENT DROPPER
• Common Device Name: SEE H11
• 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: 22123865
• Report Number: 1119779-2025-00532
• Device Sequence Number: 12581153
• Product Code: JTO
• UDI-Device Identifier: 30382902611876
• UDI-Public: (01)30382902611876(11)240910(17)250630(10)B01G247M
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: 06/30/2025
• Device Catalogue Number: 261187
• Device Lot Number: B01G247M
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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