MAUDE Adverse Event Report: MALLINCKRODT DAR SRL SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number SSV

Device Problem Connection Problem (2900)

Patient Problem Unintended Extubation (4564)

Event Date 08/19/2022

Event Type  malfunction  

Event Description

According to the reporter, during use, the speaking valve was unable to seat on trach with inner cannula in place.The tracheostomy tube had to be changed to a new one.Multiple brand new speaking valves and inner cannulas were attempted and the speaking valves worked fine with other tracheostomy tubes.The problem seems to be issue with tapering of 15mm trach connection allowing the speaking valve to slide too far and inner cannula hits bottom of speaking valve preventing seating.The patient was breathing spontaneously.Although they were participating in trach hood trials, so would be mechanically ventilated at other times during day.Able to connect to ventilator circuit, but speaking valve was loose to the point of falling off with breathing.The patient was likely receiving aerosolized meds, but it was difficult to confirm as the chart has not been fully uploaded.The patient would have received the aer osolized medications primarily while on the ventilator, and not on trach hood, nor with ssv in place.

Manufacturer Narrative

Concomitant medical products: ssv ssv phonate speaking valve x2 lot/serial #:unknown; 6cn75h 7.5mm shil cuffed trach cann lot/serial #:(b)(4); 6cn75h 7.5mm shil cuffed trach cann lot/serial #:unknown.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.

Manufacturer Narrative

Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the speaking valve was unable to sit on the trach with the inner cannula in place.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.

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 Description

According to the reporter, during use, the speaking valve was unable to sit on the trach with the inner cannula in place.The device had to be changed to a new one.Multiple brand-new speaking valves and inner cannulas were attempted.The speaking valves worked fine with other tubes.The problem seems to be an issue with the tapering of the 15-mm tracheal connection, which allows the speaking valve to slide too far and the inner cannula to hit the bottom of the speaking valve, preventing seating.The device was able to connect to the ventilator circuit, but the speaking valve was loose to the point of falling off with breathing.The patient was breathing spontaneously.However, the patient would be mechanically ventilated at other times during the day as the patient was participating in trach hood trials.The patient was likely receiving aerosolized medications primarily while on the ventilator, and not with the trach hood or speaking valve in place.

• Brand Name: SHILEY
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer (Section G): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15486458
• MDR Text Key: 306276520
• Report Number: 2936999-2022-00869
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 40884522005365
• UDI-Public: 40884522005365
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K945406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2023

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
• Device Operator: Health Professional
• Device Model Number: SSV
• Device Catalogue Number: SSV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 04/07/2023; 04/24/2023
• Supplement Dates FDA Received: 04/24/2023; 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1