MAUDE Adverse Event Report: SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	8DCT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, an rt heard an audible leak that came from the patient's tracheostomy.The ventilator showed a low minute ventilation and followed by an alarm notification.The volume of air was introduced to correct the leak, and a few minutes later the audible leak was noted again.Due to multiple introductions of air thru trach pilot balloon and still not holding volume, it was assessed that there was a leak in the current resident trach.Emergency trach changed was performed due to the constant introduction of air in the pilot cuff.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the cuff had a small cut.An inflation and deflation test were performed using a syringe.Air was applied to the cuff and it was observed the cuff deflated immediately.It was reported that there was a problem with the pilot line/balloon.The reported issue was confirmed.The most likely cause could not be established from the information available.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: with the shiley disposable cannula cuffed models (dct, dfen) the cuff and inflation system should be tested for leakage before inserting the tube.This test can be performed as follows: inflate the cuff with the volume of air indicated in tables 1 and 2.Then either observe for deflation over several minutes or immerse the tube in sterile saline and observe for air leakage.Deflate the cuff prior to insertion.To ease insertion and to guard against cuff perforation from sharp edges of cartilage, the cuff should be tapered back.This can be accomplished by first inflating the cuff.Then gently move the cuff away from the distal tip of the outer cannula towards the swivel neck plate as the residual air is removed by deflation.Do not use any sharp instruments such as forceps or hemostats that would damage the cuff when tapering it.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.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• MDR Report Key: 12375231
• Report Number: 2936999-2021-00834
• Device Sequence Number: 14428571
• Product Code: JOH
• UDI-Device Identifier: 20884522029022
• UDI-Public: 20884522029022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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 Expiration Date: 03/29/2026
• Device Model Number: 8DCT
• Device Catalogue Number: 8DCT
• Device Lot Number: 21C1126JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• 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 Age: 49 YR
• Patient Weight: 45