MAUDE Adverse Event Report: B. BRAUN CONTIPLEX ULTRA 360 CONTINUOUS NERVE BLOCK TRAY; NEEDLE, CONDUCTION, ANESTHETIC (W/INTRODUCER)

Model Number 332143

Device Problems Component Missing (2306); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2018

Event Type  No Answer Provided  

Event Description

During catheter placement of the nerve block procedure, encountered some resistance advancing the catheter, so it was removed.Catheter examined after removal and 3cm of the tip was missing.

• Brand Name: CONTIPLEX ULTRA 360 CONTINUOUS NERVE BLOCK TRAY
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/INTRODUCER)
• Manufacturer (Section D): B. BRAUN
• MDR Report Key: 7880618
• MDR Text Key: 120572815
• Report Number: MW5079827
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 332143
• Device Lot Number: 0061599649
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR