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

Model Number	3.5PCF
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Unintended Extubation (4564)
Date of Event	03/10/2022
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, the device was used for 3 weeks then began to leak air from the cuff requiring more frequent reinflation.Replacement was done but the new device would not inflate properly.After a while, was able to managed to get some air in but then could not get it back out.Eventually, managed to deflate the cuff and was able removed it (that same day) and replaced it with a new one.
Event or Problem Description
According to the reporter, after the device was used for 3 weeks, it began to leak air from the cuff, started to loosed pressure followed by increased aspiration that required more frequent reinflation.Replacement was done but the new device would not inflate properly.After a while, the device user managed to get some air in but then could not get it back out.Eventually, the user managed to deflate the cuff and removed it to replace it with a new one.It was also noted that the patient had extra secretion upon suctioning and gurgling noises.
Additional Manufacturer Narrative
Additional info: b2 (other), d9 (return date).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.
Event or Problem Description
According to the reporter, after the device was used for 3 weeks, it began to leak air from the cuff, started to loosed pressure followed by increased aspiration that required more frequent reinflation.Replacement was done but the new device would not inflate properly then once the cuff was inflated, had difficulty deflating the cuff (it would take many attempts to actually inflate or deflate).After a while, the device user managed to get some air in but then could not get it back out.Eventually, the user managed to deflate the cuff and removed it to replace it with a new one.The tube was only used for approximately an hour.It was also noted that the patient had extra secretion upon suctioning and gurgling noises.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6 correction: g1 (mfr contact first and last name, email, phone) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the inflation line was partially broken at the connection to the flange-connector.It was reported that there was a leak in the cuff without an accompanying report on whether the customer attempted inflation.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: each tube¿s cuff, pilot balloon and valve should be tested by inflation prior to tube insertion.If dysfunction is detected in any part of the inflation system, the tube should not be used.The tube and obturator are for single patient use.Duration should not exceed twenty-nine (29) days.Covidien has not substantiated use of these devices beyond 29 days.Decisions about tracheostomy tube changes should be made by the responsible physician or designate using accepted medical techniques and judgment.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
• 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: 13930598
• Report Number: 2936999-2022-00259
• Device Sequence Number: 12339671
• Product Code: JOH
• UDI-Device Identifier: 20884521779690
• UDI-Public: 20884521779690
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2022

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: 3.5PCF
• Device Catalogue Number: 3.5PCF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/11/2022; 05/12/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/29/2022; 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown