MAUDE Adverse Event Report: BECTON DICKINSON / BD BD 27 GAUGE WHITACRE SPINAL NEEDLE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/03/2021

Event Type  Injury  

Event Description

Spinal being completed for a c-section.Approximately 1.5 inches of the needle stayed in the patient.This required transfer to tertiary care center and additional procedure.Part name: tray spn whit27g3.5 l/b d/e.Fda safety report id# (b)(4).

• Brand Name: BD 27 GAUGE WHITACRE SPINAL NEEDLE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON DICKINSON / BD
• MDR Report Key: 12160539
• MDR Text Key: 261544184
• Report Number: MW5102490
• Device Sequence Number: 1
• Product Code: BSP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 23 YR