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Model Number 8888423111 |
Device Problems
Break (1069); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/29/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, before surgery, the pipe was opened and found to be damaged.It was noted that the outer packaging has been opened and must be damaged.It was also said that the catheter end trachoma was the part of the catheter that was having issues.The catheter was not repaired.There were no other defects or damages found on the product aside from the reported issue.There was no excessive force used on the product.A cleaning agent was not used on the device.As a remedial action, the product was replaced with other tubes.The patient was transferred to the operating room after remedial action was done.There was no intervention or treatment required as a result of the event.There was no reported patient outcome.
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Manufacturer Narrative
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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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Additional information: b5, 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.
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Event Description
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According to the reporter, before surgery, the pipe was opened and found to be damaged.It was noted that the outer packaging has been opened and must be damaged.It was also said that the catheter end trachoma was the part of the catheter that was having issues.The catheter was not repaired.There were no other defects or damages found on the product aside from the reported issue.There wasno excessive force used on the product.A cleaning agent was not used on the device.As a remedial action, the product was replaced with other tubes at the same day of the event.The patient was transferred to the operating room after remedial action was done.There was no intervention or treatment required as a result of the event.There was no reported patient outcome.
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Search Alerts/Recalls
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