MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY N/A; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number	405180
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Left hip injection being performed using 22gx3.5in bd whitacre pencil point spinal needle.Extreme difficulty experienced when trying to penetrate needle tip through skin.Once through, needle was very flimsy and hard to maneuver.

• Brand Name: N/A
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 15182518
• Report Number: 15182518
• Device Sequence Number: 20421961
• Product Code: BSP
• UDI-Device Identifier: 30382904051809
• UDI-Public: (01)30382904051809
• 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): 07/19/2022
• Report Date (Section F): 07/19/2022

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: 405180
• Device Catalogue Number: 405180
• Device Lot Number: 004187
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2022
• 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: Male
• Date Report Sent to FDA: 07/19/2022