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

Model Number	444SP02014
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10: concomitant products: 444sp02014, 444sp02014 14ch adt ty-care exel x10; 444sp02014, 444sp02014 14ch adt ty-care exel x10.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, an air leak was heard in the intubation tube.Observation of the device revealed that the closed system was broken on the respirator side.The system was changed immediately and five minutes after fitting the new closed system, the same problem was noted with a leak.When the closed system was replaced with a hypoxemic connector, the closed system broke, crumbling into the ventilator circuit and making it impossible to reconnect the patient and ventilate.The doctor had to intervene urgently, and the patient was ventilated using a bavu (self-filling balloon with one-way valve).There was no reported patient outcome.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The customer sent us two samples with their original package showing broken cobb connectors, with an opaque stain near the damaged areas.Visual inspection noted that there was a damaged component.It was reported that there was an air leak in product.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: do not try to refurbish.Do not reuse.Do not soak, rinse, wash, sterilize or treat with any disinfectants (in particular phenolic and alcoholic-based solutions are to be avoided).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, an air leak was heard in the intubation tube.Observation of the device revealed that the closed system was broken on the respirator side.The system was changed immediately and five minutes after fitting the new closed system, the same problem was noted with a leak.When the closed system was replaced with a hypoxaemic connector, the closed system broke, crumbling into the ventilator circuit and making it impossible to reconnect the patient and ventilate.The doctor had to intervene urgently, and the patient was ventilated using a bavu (self-filling balloon with one-way valve).

• 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: 18817948
• Report Number: 2936999-2024-00405
• Device Sequence Number: 4319622
• Product Code: BSY
• UDI-Device Identifier: 20884522035207
• UDI-Public: 20884522035207
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 04/25/2024

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: 444SP02014
• Device Catalogue Number: 444SP02014
• Device Lot Number: 22J0616FAX
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2022
• 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