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

Model Number 405234

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2020

Event Type  malfunction  

Event Description

Hard residue flecks have been found on a few bd ref# 405234 quincke needles.Approximately 3-4 of these needles have had a small, hard, dark colored fleck of residue attached to the shaft of the needle.This has been over the past six months, and only one needle will show a defect at any given time.These needles have come from at least two different lot numbers, including: lot# 8285784 and lot #9035553.None of the defective needles were used for procedure.

• Brand Name: SPINAL NEEDLE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; franklin lakes NJ 07417
• MDR Report Key: 10173769
• MDR Text Key: 195986509
• Report Number: MW5095075
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 06/09/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2023
• Device Model Number: 405234
• Device Catalogue Number: 405234
• Device Lot Number: 9035553
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1