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

Catalog Number 100/391/116CZ

Device Problems Material Fragmentation (1261); Difficult to Insert (1316); Use of Device Problem (1670)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

Report source: (b)(6).This device is same and/or similar to a device approved for distribution in the us.

Event Description

It was reported that during epidural insertion, the catheter of a portex® epidural minipack was difficult to thread through.When withdrawn, the tip was missing.Approximately 5cm of the catheter sheared off in the epidural space.An anesthetist was consulted and a plan was made for the patient.No permanent injury was reported.

Manufacturer Narrative

Additional information was received indicating that the break of the epidural catheter occurred as the catheter was withdrawn from the needle while in the patient.Reporter states that this is caused by user error, not the failure of the smiths medical product.

• Brand Name: PORTEX® EPIDURAL MINIPACK
• 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, 753 0 1; EZ 753 01
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7263254
• MDR Text Key: 99798116
• Report Number: 3012307300-2018-00240
• 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,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/04/2022
• Device Catalogue Number: 100/391/116CZ
• Device Lot Number: 3461463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2017
• 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): Other