MAUDE Adverse Event Report: COVIDIEN DAR; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	444SP02014
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during the installation of a closed suction system several leaks were observed on the fan side device.The ventilator was set to deliver a volume of 420, but only 160 was actually delivered.The patient experienced initial instability and a slight worsening of desaturation, which was quickly corrected.Two nurses and a physiotherapist attempted to tighten the system and reinforce the tubing, but due to the patient's instability, the system was replaced with a tracheostomy.The system was then replaced with a standard catheter mount product, which restored normal ventilation volumes.

• Brand Name: DAR
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): COVIDIEN; via g.bove, 2/4/6/8; mirandola modena,it 41037 ; IT 41037
• Manufacturer (Section G): COVIDIEN; via g.bove, 2/4/6/8; mirandola modena,it 41037 ; IT 41037
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22705315
• Report Number: 9680661-2025-00004
• Device Sequence Number: 8878739
• Product Code: BSY
• UDI-Device Identifier: 10884521822894
• UDI-Public: 10884521822894
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K031997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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: 444SP02014
• Device Catalogue Number: 444SP02014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/04/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown