MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW FLEXTIP PLUS EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT

Model Number IPN045607

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 09/19/2019

Event Type  malfunction  

Event Description

Epidural catheter placed by anesthesia.Insertion was uncomplicated.12 hours later, nurse encountered difficulty upon attempt at catheter removal.Anesthesia called for assistance.Upon catheter removal, tip was not intact.Missing approx.5cm of catheter tip.Patient required surgical exploration for catheter tip removal four days later.

• Brand Name: ARROW FLEXTIP PLUS EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 9744493
• MDR Text Key: 180611199
• Report Number: 9744493
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IPN045607
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F19FO158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9855 DA
• Patient Weight: 83