MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY N/A; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	303401
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During an injection,the bevel of the syringe was not level.

• Brand Name: N/A
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 8878749
• Report Number: 8878749
• Device Sequence Number: 16206757
• Product Code: FMI
• UDI-Device Identifier: 30382903034018
• UDI-Public: (01)30382903034018
• 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): 07/19/2019
• Report Date (Section F): 07/19/2019

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: 303401
• Device Catalogue Number: 303401
• Device Lot Number: 9060931
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2019
• 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: 07/19/2019