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

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

Portion of epidural catheter retained when removed.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: 13928559
• MDR Text Key: 288098174
• Report Number: MW5108520
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White