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

Model Number A4134-17

Device Problems Material Protrusion/Extrusion (2979); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2020

Event Type  malfunction  

Event Description

Pt is an adult female s/p labor epidural placement.Pt had epidural catheter placed uneventfully for labor analgesia.Post delivery, when nurse attempted to remove the catheter, she noted that plastic cover was sheared off at 5 cm and the internal wire exposed and stretching out.Md was notified immediately to evaluate epidural catheter and the md pulled the epidural wire under slow continuous pressure and it was removed completely.Did not appear to have a wire breakage.Pt was evaluated by neuro surgery, had ct imaging which did not demonstrate any foreign body.

• Brand Name: PORTEX
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10493654
• MDR Text Key: 205693161
• Report Number: 10493654
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/28/2020,07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A4134-17
• Device Catalogue Number: A4134-17
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2020
• Date Report to Manufacturer: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11315 DA
• Patient Weight: 63