MAUDE Adverse Event Report: ARROW FLEXBLOCK PERIPHERAL NERVE CATHE; ANESTHESIA CONDUCTION KIT

Device Problems Break (1069); Dull, Blunt (2407)

Patient Problem Injury (2348)

Event Type  malfunction  

Event Description

Glass ampoules in arrow brand flexblock peripheral nerve block kit shatters when trying to open them leading to user injury and potential for glass particle contamination.The company was made aware of this issue at least as far back as (b)(6) 2013 but the problem persists.Recently, practitioners have reported that the touhy needle in these kits are very dull and will not pierce the pt's skin.This has occurred with many of the users in our system at different facilities.Dates of use: approx one year.Diagnosis or reason for use: insertion of periph.Nerve catheter for pain control post op.

• Brand Name: FLEXBLOCK PERIPHERAL NERVE CATHE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW
• MDR Report Key: 3664713
• MDR Text Key: 4340051
• Report Number: MW5034818
• Device Sequence Number: 2
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/27/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other