MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SPINAL NEEDLE; NEEDLE, CONDUCTION, ANESTHETIC

Model Number 405184

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 09/12/2018

Event Type  malfunction  

Event Description

Bd 18g x 3.50in spinal needle selected for case by operating room staff.Prior to opening package, it was noted that a small hair or eyelash was in the sealed packaging.The device was held, and the packaging remains unopened.

• Brand Name: BD SPINAL NEEDLE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; franklin lakes NE 07417
• MDR Report Key: 7876370
• MDR Text Key: 120518707
• Report Number: MW5079799
• Device Sequence Number: 0
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 405184
• Device Catalogue Number: 405184
• Device Lot Number: 7348643
• Was Device Available for Evaluation?: Yes
• 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