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

Model Number	6DCFS
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Extubate (2402)
Date of Event	09/29/2018
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, while routinely cleaning the inner cannula a fraction was noticed in the upper part of the cannula and is disconnected on one side of the wings.The customer also reported that there was no patient injury.
Additional Manufacturer Narrative
Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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, while routinely cleaning the inner cannula a fraction was noticed in the upper part of the cannula and is disconnected on one side of the wings.The patient was de-cannulated and re-intubated using the same type of the device.It was also stated that the patient died but not because of the incident.
Additional Manufacturer Narrative
One sample was received for evaluation.A visual inspection was conducted, and it was observed the flange is separated from the tube and it was noticed damage on the flange which would have been detected immediately in the manufacturing process since that defect is extremely obvious; therefore, the failure mode is not confirmed as related with the manufacturing process.A dimensional test was performed to the outer cannula holes and flange lug pin and all the readings are within according to specification.Information has been added to the database and trends will continue to be monitored.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 desaroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8061203
• Report Number: 8044004-2018-00011
• Device Sequence Number: 16567278
• Product Code: JOH
• UDI-Device Identifier: 10884522006620
• UDI-Public: 10884522006620
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2019

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: 6DCFS
• Device Catalogue Number: 6DCFS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 11/14/2018; 01/31/2019
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/07/2018; 03/01/2019
• 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
• Patient Age: 66 YR
• Patient Weight: 65