MAUDE Adverse Event Report: MALLINCKRODT DAR SRL DAR; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	444SP02010
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
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
According to the reporter, intra-operatively, the device had an air leak.The leak rate of the ventilator reached fifty percent.The circuitry was inspected, but no problems were found.After replacing the defective part, the leak rate settled at ten percent.The rotating valve was in the off position, and the sleeve was not inflated.There was no patient injury.
Additional Manufacturer Narrative
H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the connectors were dimensionally inspected, and all the measurements were inside their specification limits.Performed leakage test and the result failed.It was reported that the device had an air leak.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.

• Brand Name: DAR
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer (Section G): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20616016
• Report Number: 2936999-2024-01704
• Device Sequence Number: 18348134
• Product Code: BSY
• UDI-Device Identifier: 10884521822870
• UDI-Public: 10884521822870
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2025

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: 444SP02010
• Device Catalogue Number: 444SP02010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown