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

Catalog Number 100/391/118CZ

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

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

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that the catheter in the epidural mini pack system, broke during insertion.A portion if the catheter remained in the patient's body.The broken catheter was removed by surgery, and the event was resolved.The patient's condition was reported as stable.

Manufacturer Narrative

One catheter was returned for analysis in a plastic bag with its original unit pack.Under visual inspection we noticed that catheter is not complete; the tip was missing.The returned sample was measured and compared to a non-used sample finding that 10.7cm were missing.The catheter was noted to be cut by a sharp object under magnification.The manufacturing process was reviewed.The reported complaint occurred during the procedure with its most probable cause of cut by the tuohy needle when the catheter was pulled back.Ifu was reviewed finding that it states to never pull back the catheter through the epidural tuohy needle.Based on the evidence, the complaint is confirmed with the root cause being user interface as the reported failure was cause by the customer during practice which is in conflict with the instructions for use (ifu).

• Brand Name: PORTEX® EPIDURAL MINIPACKS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7891755
• MDR Text Key: 120821016
• Report Number: 3012307300-2018-03860
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2022
• Device Catalogue Number: 100/391/118CZ
• Device Lot Number: 3488259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention