MAUDE Adverse Event Report: ARROW INTERNATIONAL FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT; FLEXTIP PLUS EPIDURAL KIT

Model Number SJ-05501

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/10/2017

Event Type  malfunction  

Event Description

An obstetric patient had a continuous infusion labor epidural using an arrow brand catheter from a ready-made insertion kit supplied by arrow.No problems were encountered during insertion or use of the catheter for the labor, but upon removal by the registered nurse, who was highly experienced with the removal of epidural catheters, the catheter fractured.This resulted in approximately 3.5cm of the distal-most part of the catheter remaining in the epidural space in front of the body of l4, with the most distal part of the catheter positioned in the right of the epidural space.Patient had a labor epidural infusion on (b)(6) 2017.Upon removal of the catheter later the same day, the catheter fractured, and 3.5cm remained in the patient's body.Date of use: one day.Diagnosis or reason for use: pain relief for labor.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT
• Type of Device: FLEXTIP PLUS EPIDURAL KIT
• Manufacturer (Section D): ARROW INTERNATIONAL; reading PA 19605
• MDR Report Key: 6352556
• MDR Text Key: 68272541
• Report Number: MW5068031
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: SJ-05501
• Device Lot Number: 23F16K02763001128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Weight: 100