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Model Number 444SP02314 |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, the adt trach tube was kinked, that unable to perform normal suction operation.There was no patient involvement.Medtronic's initial evaluation of the incident device found the suction valve showed the cap turned in the wrong direction, which resulted in a broken suction valve.
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Manufacturer Narrative
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D10 concomitant product: 444sp02314, 444sp02314 14ch adt trach ty-care exel (lot#19g0760fax); 444sp02314, 444sp02314 14ch adt trach ty-care exel (lot#19g0760fax); 444sp02314, 444sp02314 14ch adt trach ty-care exel (lot#19g0760fax).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.
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Manufacturer Narrative
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Evaluation summary: medtronic conducted an investigation based upon all information received.Four devices were available for evaluation.In one of the three, the suction valve showed the cap turned in the wrong direction, which resulted in a broken suction valve.The other samples were visually and functionally checked, performing a simulation of its usage and no issues were found.None of the samples returned showed any issues in the suction tube.The suction tube did not show any issues and the suction valve did not return in its original condition.The other samples were functionally checked, performing a simulation of their usage, and found no issues with the product usability.It was reported that the adt trach tube was kinked, that unable to perform normal suction operation.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.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.
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Search Alerts/Recalls
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