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

Model Number	305766
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While injecting bicillin medication via a required 18 gauge sharp (bd eclipse needle (ref# (b)(4).The pink safety shaft cover malfunctioned.The plastic safety sleeve fell to the floor leaving the used sharp exposed.Writer was able to immediately dispose of the needle in the sharp's container and retrieve the broken cover from the floor.

• Brand Name: BD ECLIPSE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 15814339
• Report Number: 15814339
• Device Sequence Number: 12113023
• Product Code: FMI
• UDI-Device Identifier: 30382903057666
• UDI-Public: (01)30382903057666
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 11/08/2022
• Report Date (Section F): 11/08/2022

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: 305766
• Device Catalogue Number: 305766
• 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: 11/17/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2022
• 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: 11/08/2022