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Model Number 8888145044CP |
Device Problem
Migration (4003)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/05/2023 |
Event Type
Injury
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Event Description
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According to the reporter, the line fell out at home.The patient was admitted to the hospital and the second line was inserted on the same day.
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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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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, during post dialysis at home, the catheter line fell out at home.The device partially moved out of place.There was no leak and tego was utilized.There was no luer adapter issue and the catheter was not repaired.Chloraprep was the cleaning agent used on the device.Flushing was not performed prior to use.Nothing unusual was observed on the device prior to use.No other products were utilized with the device.There were no damages noted on the product.There was no securement wing issue and there was no clothing factor that might have not contributed to the event.The catheter was maintained in place by sutures and dressing.The patient was admitted to the hospital and the second line was inserted on the same day.It was mentioned that line was removed, antibiotic cover, blood was taken as the remedial action done to resolve the issue.On may 31, 2023, the line cuff was out and fell out and it was removed by the renal doctor.The patient had no further issues.
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Search Alerts/Recalls
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