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

Model Number 4916-18

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 06/24/2021

Event Type  malfunction  

Event Description

Portex® epidural catheter removed without the tip intact.

• 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: 12301114
• MDR Text Key: 265823488
• Report Number: 12301114
• 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: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4916-18
• Device Lot Number: 3528403
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA