MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. WHITACRE 25G NEEDLE; ANESTHESIA CONDUCTION KIT

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/14/2020

Event Type  Injury  

Event Description

Pt.Admitted elective minimally invasive l hip arthroplasty which was complicated by a retained portion of a spinal needle in patient's lumbar spine during attempt for a spinal block pre-operatively.A whitacre, 25 g, 9 cm in length needle and attempted a spinal placement midline at l2-3.On the first attempt, csf was unable to be obtained.Upon withdrawal of introducer and needle, the spinal needle noted to be broken.Fda safety report id# (b)(4).

• Brand Name: WHITACRE 25G NEEDLE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10114196
• MDR Text Key: 193953301
• Report Number: MW5094801
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 66 YR
• Patient Weight: 137