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

Model Number	444SP02012
Medical Device Problem Codes	Connection Problem (2900); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when testing with a test lung before starting the ventilator, there was a leak noted on the six devices.There was also a crack in the y-piece region (on the ventilator side).There was no patient injury.
Additional Manufacturer Narrative
Concomitant product: pli 10 444sp02012, 444sp02012 12ch adt ty-care exel x10 21l0527fax pli 20 444sp02012, 444sp02012 12ch adt ty-care exel x10 21l0527fax pli 30 444sp02012, 444sp02012 12ch adt ty-care exel x10 21l0527fax pli 50 444sp02012, 444sp02012 12ch adt ty-care exel x10 21l0527fax pli 60 444sp0201, 444sp02012 12ch adt ty-care exel x10 21l0527fax pli 70 444sp02012, 444sp02012 12ch adt ty-care exel x10 21l0935fax.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.
Additional Manufacturer Narrative
Additional information: b5, g3.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 when testing with a test lung before starting the ventilator, there was a leak noted on the seven devices.There was also a crack in the y-piece region (on the ventilator side).There was no patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the connectors were dimensionally inspected, and all measurements were inside their specification limits.Functionally, the device was inspected performing the leakage test, and the result was fail.It was reported that when testing with a test lung before starting the ventilator, there was a leak noted on the seven devices.There was also a crack in the y-piece region (on the ventilator side).The reported issues 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: 21601038
• Report Number: 2936999-2025-00176
• Device Sequence Number: 4373795
• Product Code: BSY
• UDI-Device Identifier: 20884522035191
• UDI-Public: 20884522035191
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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
• Operator of Device: Health Professional
• Device Model Number: 444SP02012
• Device Catalogue Number: 444SP02012
• Device Lot Number: 21L0527FAX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 05/15/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 03/21/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES ON H11
• Patient Sex: Unknown