MAUDE Adverse Event Report: MMJ SA DE CV(USD) SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 8PERC

Device Problem Disconnection (1171)

Patient Problem Extubate (2402)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device had trach tube that broke at the flange, inner cannula, no longer secure and slipping out of place.Trach tube required urgent changing.Change was difficult under the circumstances and patient was in distress.

Manufacturer Narrative

H3 evaluation summary: one sample of device was received for evaluation and the reported issue was confirmed.The received samples are one outer cannula and one size inner cannula.A visual inspection was performed and it was observed the tube presents signs of being used, the snap head connector is detached from the tube, the snap head and the proximal end of the tube were observed under the uv lamp according to process instruction and it was observed, bonding agent was present in the sample plus the sample presents marks of being bonded.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
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 9420569
• MDR Text Key: 169405558
• Report Number: 2936999-2019-00990
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 30884522006709
• UDI-Public: 30884522006709
• Combination Product (y/n): N
• PMA/PMN Number: K884730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8PERC
• Device Catalogue Number: 8PERC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention