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

Model Number	305564
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
When utilizing the 10ml syringe to inject medication the medication leaked around the plunger, out of the syringe, and onto the patient.This patient was not negatively impacted and unfortunately, the device was not retained.It is not known what medication was being administered.

• Brand Name: BD SAFETY-LOK
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 8284524
• Report Number: 8284524
• Device Sequence Number: 18873947
• Product Code: FMI
• UDI-Device Identifier: 00382903055647
• UDI-Public: (01)00382903055647
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2019
• Report Date (Section F): 01/07/2019

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: 305564
• Device Catalogue Number: 305564
• Device Lot Number: 8166897
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/07/2019