MAUDE Adverse Event Report: MALLINCKRODT DAR SRL DAR; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number 4-076408-00

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

According to the reporter, the breathing system's filter case was damaged based on the photo provided.There was no patient involvement.Medtronic's initial evaluation of the incident device found component - damaged/broken/cracked.

Manufacturer Narrative

D10 concomitant product: 4-076408-00 repl neomode filter x12 (lot#: 20c367fax).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
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• 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: 19102091
• MDR Text Key: 340808724
• Report Number: 2936999-2024-00592
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 10884521087941
• UDI-Public: 10884521087941
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K941676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4-076408-00
• Device Catalogue Number: 4-076408-00
• Device Lot Number: 20C367FAX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE NOTE ON H11.