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

Model Number 405184

Patient Problem Insufficient Information (4580)

Event Date 12/03/2023

Event Type  malfunction  

Event Description

When performing a bedside arthrocentesis, the md found that the stylus of the 18g x 3.50-inch bd spinal needle [(b)(4), redacted date, lot 2340678], wouldn't thread back into the needle.He found that 3 other needles had the same problem.The 20g spinal needles didn't have this issue.This would have been a more significant issue had these needles been used for a lp.

• Brand Name: NEEDLE SPINAL
• 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: 18408480
• MDR Text Key: 331488353
• Report Number: 18408480
• Device Sequence Number: 1
• Product Code: BSP
• 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: 12/08/2023

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: 405184
• Device Catalogue Number: 405184
• Device Lot Number: 2340678
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1