MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	110880
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	11/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit ventilation volume decrease alarm was generated and cuff check was performed; however, the cuff pressure was appropriate.Customer stated tube abnormality was suspected, although placement position was checked with fiber, there was no problem, the cuff leak would not stop, and water was also being pooled in the inflation line heavily, it was judged that the condition was unmanageable and the tube was replaced.Reintubation was required.
Additional Manufacturer Narrative
H3 evaluation summary: one sample of device was returned for evaluation.An inflation test was performed and it inflated without any issue.The returned unit was leak tested under water and no leakage was detected.The returned unit remained inflated for a 24- hour period and no leakage was detected.The reported defect could not be detected on the unit returned for evaluation.All of the products undergo a four hour inflate/deflate test and it is at this stage of the process that any defects are removed from the lot.The most probable root cause is an inflation device remained in the inflation valve allowing the air to escape.Instructions for use (ifu) states: syringes, three-way stopcocks or other cuff inflation devices should not be left inserted in the inflation valve for extended periods of time.Information has been added to the database and trends will continue to be monitored.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
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 9387679
• Report Number: 8020889-2019-00165
• Device Sequence Number: 14054087
• Product Code: BTR
• UDI-Device Identifier: 40884521068231
• UDI-Public: 40884521068231
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 110880
• Device Catalogue Number: 110880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention