MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. SPINAL 22G WHITACRE FORTEX; SPINAL INTRATHECAL

Model Number NLD-15545C-21

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/25/2016

Event Type  malfunction  

Event Description

Two incidents.One spinal given in operating room for pregnant pt for cystoscopy.Sab placed w/o any issues.Waited 15 minutes and pt had no effect from sab.Had to convert to general anesthetic.(b)(6), 1 spinal given for post partum tubal.Sab took close to 12 min to "set up." surgeon still had to inject local in order to keep pt comfortable.Ref # nld 15545c-21, lot 3115757 ref # nld 15545c-21, lot 3093098.

• Brand Name: SPINAL 22G WHITACRE FORTEX
• Type of Device: SPINAL INTRATHECAL
• Manufacturer (Section D): SMITHS MEDICAL ASD INC. ; keene NH 03431
• MDR Report Key: 5513429
• MDR Text Key: 40949510
• Report Number: MW5060963
• Device Sequence Number: 2
• Product Code: CAZ
• 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: 03/16/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: NLD-15545C-21
• Device Lot Number: 3093098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR