MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ VOGES-PROSKAUER A REAGENT DROPPERS; DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Catalog Number	261192
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: this memo summarizes the findings on your recent complaint (b)(4) for product 261192 (dropper voges-proskauer a), batch number b01h316m.It was reported by the customer that the ample broke causing injury.When squeezing to break ampule the glass broke through the plastic and cut a student.Historical complaint data for sku 261192 shows no trend concerning the reported issue over the past year.Retain samples have been retrieved for visual inspection, all samples were found compliant with product specifications.A bhr (batch history record) review did not show any issues with the ampule.No deviations were found either during the production process or during the final checks for lot release.No physical returns or images were provided for analysis based on the investigation the complaint could not be confirmed.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 one bd bbl¿ voges-proskauer a reagent droppers, a student was injured when glass broke through the plastic while squeezing the ampule to open it.There was no health impact or consequence reported.
Event or Problem Description
It was reported that while using one bd bbl¿ voges-proskauer a reagent droppers, a student was injured when glass broke through the plastic while squeezing the ampule to open it.There was no health impact or consequence reported.
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.E1: initial reporter phone #: (b)(6).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 and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• Brand Name: BD BBL¿ VOGES-PROSKAUER A REAGENT DROPPERS
• Common Device Name: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 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: 24754189
• Report Number: 1119779-2026-00594
• Device Sequence Number: 8771990
• Product Code: JTO
• UDI-Device Identifier: 30382902611920
• UDI-Public: (01)30382902611920(17)280531(10)B01H316M
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 261192
• Device Lot Number: B01H316M
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown