MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	5.0PDC
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	01/23/2020
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, during use, the device had an air leak.It was indicated that replacement of tube was required.
Additional Manufacturer Narrative
Evaluation summary: one sample of device was received for evaluation.The reported event was confirmed.An inflation/deflation test was performed and it was observed the cuff deflated immediately.A visual inspection was performed and it was observed the inflation line is partially broken at the connection to the flange-connector.All manufacturing controls were found effective to detect the reported failure mode.Instructions for use (ifu) information: always test the cuff and inflation system for leakage before inserting the tube.This test can be performed as follows: inflate the cuff with the volume of air indicated in table 4.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.No corrective actions are needed at this time since the confirmed failure (inflation line leak) would have been detected immediately during the 100% inflation/ deflation test.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 TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 9670611
• Report Number: 2936999-2020-00095
• Device Sequence Number: 2912886
• Product Code: JOH
• UDI-Device Identifier: 20884522029121
• UDI-Public: 20884522029121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2020

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: 5.0PDC
• Device Catalogue Number: 5.0PDC
• Device Lot Number: 18J086JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 05/15/2020
• 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