MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AMBIT CONTINUOUS NERVE BLOCK; ANESTHESIA CONDUCTION KIT

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/23/2020

Event Type  malfunction  

Event Description

Self-removal of infraclavicular peripheral nerve block post-surgery.Upon removal, the catheter tip broke near the coils, roughly six inch catheter tip retained and required surgical removal.Patient had ongoing shoulder pain, retained object was found via x-ray on (b)(6) 2021.Metal tip catheter remnant at anterior axilla.Fda safety report id # (b)(4).

• Brand Name: AMBIT CONTINUOUS NERVE BLOCK
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 12518490
• MDR Text Key: 273310829
• Report Number: MW5104151
• Device Sequence Number: 1
• Product Code: CAZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR