MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SPINAL KIT 24G. EUROPEAN POINT PENCIL NEEDLE; ANESTHESIA CONDUCTION KIT

Model Number NEPI-NLD-49651-24

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/22/2021

Event Type  Injury  

Event Description

Needle broke during spinal anesthesia attempt, resulting in retained spinal needle fragment.

• Brand Name: SPINAL KIT 24G. EUROPEAN POINT PENCIL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 11595298
• MDR Text Key: 243560461
• Report Number: MW5100408
• Device Sequence Number: 1
• Product Code: CAZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEPI-NLD-49651-24
• Device Lot Number: 4061623
• Was Device Available for Evaluation?: 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR