MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number A2744-17/27

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

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

Event Date 12/25/2018

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

One epidural catheter and connector were received for evaluation.Upon visual inspection of the flat filter and connector, no discrepancies were noted.Visual inspection of the returned catheter revealed that the tip was bent approximately 5mm from the distal end.However, the catheter tip appeared to be smooth and rounded.All catheter eyes were noted to be present and were properly formed.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, impeding the flow.The presence of the dried substance may support the customer's claim for the occurrence of an intravascular penetration.However, the returned catheter was found to be within specification and was fully formed with a smooth, rounded tip.The cause of the reported issue was not determined.

• Brand Name: PORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8276016
• MDR Text Key: 134063527
• Report Number: 3012307300-2019-00365
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30351688059301
• UDI-Public: 30351688059301
• 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: 03/19/2019

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
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: A2744-17/27
• Device Lot Number: 3713218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1