MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC FLEX TIP PLUS EPIDURAL CATHETER; CATHETER, CONDUCTION, ANESTHETIC

Lot Number 23F21C0172

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2021

Event Type  malfunction  

Event Description

While removing catheter from patient there was resistance.When the catheter was removed it was partially broken at the tip.This is the 3rd instance we've had with these catheters.Fda safety report id # (b)(4).

• Brand Name: FLEX TIP PLUS EPIDURAL CATHETER
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC
• MDR Report Key: 12814407
• MDR Text Key: 280935188
• Report Number: MW5105313
• Device Sequence Number: 1
• Product Code: BSO
• 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: 11/10/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 23F21C0172
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female