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

Catalog Number 100/391/116CZ1

Device Problems Material Fragmentation (1261); Occlusion Within Device (1423); Deformation Due to Compressive Stress (2889)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

It was reported that the epidural catheter kinked upon insertion, and therefore prevented injection of the drug.There were three separate occurrences of this situation.One required complete removal of the catheter and replacement with a new one.Two required withdrawal of the catheter to enable injection.The consequence to the patient was described as follows: "the patient had to return to theatre for a second procedure to see if they could locate the catheter tip.".

• Brand Name: PORTEX EPIDURAL CONTINUOUS TRAYS
• 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 CZECH REPUBLIC A. S.; olomoucká 306; hranice 1 - mesto; hranice, 75301 ; EZ 75301
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7537123
• MDR Text Key: 109017565
• Report Number: 3012307300-2018-01789
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/29/2023
• Device Catalogue Number: 100/391/116CZ1
• Device Lot Number: 3573303
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention