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

Model Number 405180

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2022

Event Type  malfunction  

Event 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
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 15182518
• MDR Text Key: 297429884
• Report Number: 15182518
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904051809
• UDI-Public: (01)30382904051809
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 07/19/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male