MAUDE Adverse Event Report: TELEFLEX INCORPORATED FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK KIT; ANESTHESIA CONDUCTION KIT

Lot Number 23F20A0422

Device Problems Defective Component (2292); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2020

Event Type  malfunction  

Event Description

The tubing in the flexblock kit is defective and not allowing fluid to pass through the tubing.

• Brand Name: FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10828595
• MDR Text Key: 215897002
• Report Number: 10828595
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 23F20A0422
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1