MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Model Number 125139

Device Problem Gas/Air Leak (2946)

Patient Problem Unintended Extubation (4564)

Event Type  malfunction  

Manufacturer Narrative

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 Description

According to the reporter, the device had an air leak through a hole during the procedure.The tube was replaced.

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 the bronchial cuff inflated without any issue however the tracheal cuff deflated rapidly.Functionally, the tracheal cuff was leak tested under water and leakage was noted from the main body of the tracheal cuff.Further examination of the tracheal cuff using the showed that there was a marking on the tracheal cuff body for a distance of 5mm.The marking was serrated like in appearance, which has numerous slits along its length of 5mm al measuring 0.13mm in length.It was reported that the device had an air leak through a hole during the procedure.The tube was replaced.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.The instructions included with this device provide the following guidance: various bony anatomical structures within the intubation route or any intubation tools with sharp surfaces present a threat to maintaining cuff integrity.Care must be taken to avoid damaging the thin-walled cuffs during intubation which would create the need to subject the patient to the trauma of extubation and re-intubation.If either cuff is damaged, the tube should not be used.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.

• Brand Name: SHILEY
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer (Section G): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16512829
• MDR Text Key: 311481252
• Report Number: 8020889-2023-00038
• Device Sequence Number: 1
• Product Code: BYE
• UDI-Device Identifier: 10884521620032
• UDI-Public: 10884521620032
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K912240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 125139
• Device Catalogue Number: 125139
• Device Lot Number: 202003516X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2020
• 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