MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q FLUID DISPOSABLE TUNNELER 30.5 11GA; REGIONAL ANESTHESIA

Model Number	FT11X12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Code Available (3191)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 21-oct-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: unknown.Flow rate: unknown.Procedure: video assisted thoracoscopy with truitt placement.Cathplace: intercostal region.It was reported an incident that occurred during an ultrasound assisted placement of a continuous intercostal nerve block for pain management due to fractured ribs.During the procedure the surgeon "fully seated" the tunneler device towards the scapula.The tunneler was then removed leaving the t-peel sheath in place.The surgeon then began to thread the catheter into the t-peel sheath when bright red blood was noted to be coming from the tunnelers insertion sight.The clinicians identified something was wrong and called for assistance.The patient was "coded" and had to undergo an "open chest procedure".After 2-hours, the patient was stabilized and brought to the recovery room.No additional information was provided.

• Brand Name: ON-Q FLUID DISPOSABLE TUNNELER 30.5 11GA
• Common Device Name: REGIONAL ANESTHESIA
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9218754
• Report Number: 2026095-2019-00162
• Device Sequence Number: 16827841
• Product Code: BSO
• UDI-Device Identifier: 10680651135435
• UDI-Public: 10680651135435
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FT11X12
• Device Catalogue Number: 101354302
• Device Lot Number: ANP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention