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

Model Number	86549
Medical Device Problem Codes	Use of Device Problem (1670); Defective Component (2292); Gas/Air Leak (2946)
Health Effect - Clinical Codes	Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
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 surgery, the balloon did not inflate.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, g1.(mfr contact first name, last name, email and phone number), g3 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.
Event or Problem Description
According to the reporter, during surgery, the pilot balloon did not inflate (possible air leak).The fault was detected almost immediately after intubation and was replaced by a new device.The "pneumotaponator" had cut, tear or hole.It was noted that the "pneumotaponator" is a cuff located at the distal end of the tube that is inflated with a small volume of air after intubation, with the purpose of obturating the airway, establishing an inhalation system, no leaks and avoiding pulmonary aspiration.Reintubation was required.
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, during surgery, the balloon did not inflate, possible air leak.The fault was detected almost immediately after intubation and was replaced by a new device.The pneumotaponator had cut, tear or hole.It was noted that the pneumotaponator is a cuff located at the distal end of the tube that is inflated with a small volume of air after intubation, with the purpose of obturating the airway, establishing an inhalation system no leaks and avoid pulmonary aspiration.Reintubation was required.

• Brand Name: SHILEY
• 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
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: tanja beshear ; 5920 longbow drive; boulder, CO 80301 ; 3035306434
• MDR Report Key: 14225832
• Report Number: 2936999-2022-00356
• Device Sequence Number: 4194452
• Product Code: BTR
• UDI-Device Identifier: 10884521211650
• UDI-Public: 10884521211650
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K790575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2022

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: 09/01/2025
• Device Model Number: 86549
• Device Catalogue Number: 86549
• Device Lot Number: 202009087X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 05/10/2022; 06/03/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/26/2022; 06/20/2022
• Date Device Manufactured: 09/07/2020
• 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 Sex: Female
• Patient Weight: 60 KG