MAUDE Adverse Event Report: MEDICOMP MEDICAL MEDICOMP DUAL TRACH SWIVEL ELBOW WITH SUCTION PORT

Model Number	MC-4475
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have very little information at this time.We were not notified unit almost two years after the incident.
Event or Problem Description
Our initial and only notification was on april 11, 2024 from the law firm of beausay & nichols.Their letter stated the following: for steven's bronchoscopy, the bronchoscopist lterally got the bronchoscope "stuck" in the adapter and could not advance or maneuver the bronchoscope, requiring that he remove the bronchoscope and endotracheal tube as one unit.Inthe process of the bronchoscope getting stuck and removing the ett, steven began desaturating and eventually arrested.A code blue was initiated but steven sustained a severe anoxic brain injury as a result of this incident.

• Brand Name: MEDICOMP DUAL TRACH SWIVEL ELBOW WITH SUCTION PORT
• Common Device Name: DUAL TRACH SWIVEL ELBOW WITH SUCTION PORT
• Manufacturer (Section D): MEDICOMP MEDICAL; 12535 316th avenue nw; princeton MN 55371
• Manufacturer (Section G): MEDICOMP MEDICAL; 12535 316th avenue nw; princeton MN 55371
• Manufacturer Contact: duncan johnson ; 12535 316th avenue nw; princeton, MN 55371 ; 7633894473
• MDR Report Key: 19537187
• Report Number: 2183585-2024-00001
• Device Sequence Number: 12368406
• Product Code: BZA
• UDI-Device Identifier: 00858409005344
• UDI-Public: 00858409005344
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K951446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC-4475
• Device Catalogue Number: MC-4475
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 15 YR
• Patient Sex: Male