MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, CONDUCTION, ANESTHETIC

Lot Number 23F21A0064

Device Problems Leak/Splash (1354); Material Separation (1562); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 05/15/2021

Event Type  malfunction  

Event Description

Arrow flextip plus(r) epidural catheterization kit was opened by health care provider.The lidocaine 1% and 10ml saline solution vials were empty, and the tops popped off.No liquid was found in the tray.

• Brand Name: ARROW
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 11946146
• MDR Text Key: 254506204
• Report Number: 11946146
• 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
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 23F21A0064
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2021
• Date Report to Manufacturer: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA