MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. EPIDURAL MINI PACK SYSTEM; ANESTHESIA CONDUCTION KIT

Catalog Number 100/391/116CZ1

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 07/09/2018

Event Type  Injury  

Event Description

It was reported that 7 cm of the epidural catheter broke off inside the patient who was undergoing a caudal epidural.The patient had to undergo a further procedure to remove the retained catheter.No further complications were reported.

Manufacturer Narrative

The investigation of the complaint was limited because no sample was returned.Due to the fact that reported issue occurred during procedure it is the most probable that the catheter was cut off by tuohy needle when catheter was pulled back which is in conflict with instruction for use l6308 rev.100, warnings, point 1: "never pull back the catheter through the epidural tuohy needle as this can result in the catheter being cut and left in the epidural space.If catheter insertion difficulties are encountered, the epidural tuohy needle and catheter should be removed carefully together as a single unit, and the procedure repeated".

• Brand Name: EPIDURAL MINI PACK SYSTEM
• 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.; olomouck 306; hranice 1 - mesto; hranice, 75301 ; EZ 75301
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7789480
• MDR Text Key: 117310020
• Report Number: 3012307300-2018-03297
• 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,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2020
• Device Catalogue Number: 100/391/116CZ1
• Device Lot Number: 2994496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention