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

Device Problems Difficult to Insert (1316); Material Too Rigid or Stiff (1544)

Patient Problems Infiltration into Tissue (1931); Perforation (2001)

Event Type  malfunction  

Manufacturer Narrative

Date of event: possible event date mid (b)(6) 2018.

Event Description

Information was received that a smiths medical portex epidural catheter was too stiff, causing vascular penetration.No additional adverse patient effects were reported.

• Brand Name: PORTEX EPIDURAL CATHETER
• 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 NORTH AMERICA; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8276015
• MDR Text Key: 134063630
• Report Number: 3012307300-2019-00363
• 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: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2018
• 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: N
• Patient Sequence Number: 1