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

Model Number	405181
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Stylet extends past the tip of the needle.

• Brand Name: BD SPINAL NEEDLE,QUINCKE
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 7112155
• Report Number: 7112155
• Device Sequence Number: 1933502
• Product Code: BSP
• UDI-Device Identifier: 00382904051815
• UDI-Public: (01)00382904051815
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2017
• Report Date (Section F): 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/31/2022
• Device Model Number: 405181
• Device Catalogue Number: 405181
• Device Lot Number: 7125998
• Other Device ID Number: 22G X 3.50IN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2017
• 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: 12/06/2017