MAUDE Adverse Event Report: B. BRAUN AESCULAP JAPAN CO., LTD. CONTIPLEX TUOHY CONTINUOUS NERVE BLOCK SET; ANESTHESIA CONDUCTION KIT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Placed femoral nerve catheter for improved pain management in this patient on monday, (b)(6) 2023.Removed this nerve catheter today and found that the blue tip of the (braun) nerve catheter was missing.Measured the remaining catheter and it appears that approximately 2mm is missing from the end of the catheter.

• Brand Name: CONTIPLEX TUOHY CONTINUOUS NERVE BLOCK SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN AESCULAP JAPAN CO., LTD.
• MDR Report Key: 16727045
• MDR Text Key: 313207637
• Report Number: MW5116551
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White