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

Model Number 352/5877

Device Problems Crack (1135); Use of Device Problem (1670)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant products: 300/13315, 300/13315 armonia ext breath luer elb (lot#unknown) 352/5877, 352/5877 hygrobac s elecst fhme x25 (lot#unknown) 352/5877, 352/5877 hygrobac s elecst fhme x25 (lot#unknown) 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 Description

According to the reporter, prior to use, during the pre-use leak test, devices did not pass the test and an abnormality was discovered.There was a crack in the circuit and a leak sound was heard from the anesthesia circuit.There was no patient involvement.

• 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: 18988513
• MDR Text Key: 338761874
• Report Number: 2936999-2024-00516
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 20884522039649
• UDI-Public: 20884522039649
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K941381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352/5877
• Device Catalogue Number: 352/5877
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• 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 H11