MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD ECLIPSE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	305759
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Safety lock on needle did not secure leaving sharp exposed and when disposing needle in sharps container poked employee through gloves into thumb producing blood.

• Brand Name: BD ECLIPSE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr.; franklin lakes NJ 07417
• MDR Report Key: 22628608
• Report Number: 22628608
• Device Sequence Number: 20909326
• Product Code: FMI
• UDI-Device Identifier: 00382903057597
• UDI-Public: (01)00382903057597
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/09/2025
• Report Date (Section F): 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: Health Professional
• Device Model Number: 305759
• Device Catalogue Number: 305759
• Device Lot Number: 4250308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/09/2025