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 (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.

Manufacturer Narrative

One catheter was returned for evaluation.Upon visual inspection, it was found to be in good physical condition.It was noted a dried substance was present throughout the inside of the catheter.As functional testing, attempts were made to push fluid through the catheter/connector assembly (using a fluid filled syringe) to observe for flow from the catheter eyes.This test was not successful due to the dried substance inside the catheter which impeded flow.The distal tip of the catheter was passed through the hub of the needle until it passed through the bevel tip.A slight resistance was observed as the tip of the catheter emerged from the bevel of the needle.However, this is considered to be an acceptable fit.The reported customer complaint was unable to be confirmed.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• 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
• MDR Report Key: 8276020
• MDR Text Key: 134063764
• Report Number: 3012307300-2019-00368
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1