MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® EPIDURAL KIT; ANESTHESIA CONDUCTION KIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paralysis (1997); Arachnoiditis, Spinal (2390)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a portex® epidural kit was involved in a labor epidural procedure.The patient had an apparent flaccid paralysis of both legs, with a sensory level of t11, post-epidural.The patient showed complete cauda equina syndrome with arachnoiditis in lumbar region on an mri scan after the procedure.The reporter noted that the adverse incident was "very unlikely" related to a device issue.The patient had not recovered as of more than 6 weeks after the incident.The patient was treated with steroids and antibiotics after emergency imaging.No improvement had been noted.The patient was transferred to a spinal rehabilitation center.

• Brand Name: PORTEX® EPIDURAL KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; unit 4 bradwood court st.; 1 crispin way; rossendale, BB4 4 PW; UK BB4 4PW
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6271123
• MDR Text Key: 65533307
• Report Number: 3012307300-2017-00209
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 18 YR