MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SPROTTE NEEDLE IN SPINAL TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number 15858-21

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/07/2019

Event Type  Injury  

Event Description

A 24g, 3.5 inch spinal anesthesia needle broke off during insertion.There was minimal to no resistance at the time of insertion.Withdrawn without resistance.At the time of withdrawal it was realized that a 1+inch portion remained in the pt.Retained needle was unable to be removed at the time and was retained in the pt for the pt was undergoing a c-section.Retained needle will be removed at a later time.Fda safety report id# (b)(4).

• Brand Name: SPROTTE NEEDLE IN SPINAL TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8615619
• MDR Text Key: 145366093
• Report Number: MW5086671
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/14/2019

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 Catalogue Number: 15858-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2019
• 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): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 183