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

Model Number	18875
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	10/01/2018
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, they were unable to intubate due to an air leak.After removing the tube, they filled it with normal saline and observed a hole in the balloon.The patient needed to be intubated three times and that medicine was issued to prevent coding.
Additional Manufacturer Narrative
Additional information: concomitant medical products, date rec¿d by mfr, device evaluated by mfr.Evaluation summary: one sample was received for evaluation.The failure tear in cuff was confirmed in the received sample.Manufacturing process was reviewed and currently, there is no potential risk and the below condition was found.An inflation/deflation test was performed for all products.The operator inspects all products for no leaks and segregates the defective parts.All products have a resting time of 2 hours.Once the part is inspected visually, then the instruction provides the guidelines to deflate the cuff.All manufacturing controls were found acceptable and effective to detect the reported failure mode.No corrective actions are needed at this time since the confirmed failure (tear in cuff) would have been detected during the 100% inflation/ deflation test.The failure mode is not confirmed as related with the manufacturing process.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.

• Brand Name: TAPERGUARD
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8081270
• Report Number: 2936999-2018-00700
• Device Sequence Number: 215664
• Product Code: BTR
• UDI-Device Identifier: 30884521032532
• UDI-Public: 30884521032532
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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 Expiration Date: 06/05/2023
• Device Model Number: 18875
• Device Catalogue Number: 18875
• Device Lot Number: 18F0127JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 02/28/2019
• 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