MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC ARROW, FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Model Number ARROW, FLEXTIP PLUS EPIDURAL CAT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/30/2021

Event Type  malfunction  

Event Description

Retained epidural catheter tip.Fda safety report id# (b)(4).

• Brand Name: ARROW, FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC
• MDR Report Key: 12287482
• MDR Text Key: 265580646
• Report Number: MW5103043
• Device Sequence Number: 1
• Product Code: CAZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARROW, FLEXTIP PLUS EPIDURAL CAT
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1