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Model Number 8888145044CP |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Type
Death
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Event Description
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According to the reporter, the luer adapter broke/cracked while using tego.The dialysis treatment was stopped.The patient died.
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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: b2 (date of death), 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, the luer adapter broke/cracked while using tego.The dialysis treatment was stopped.Nothing unusual was observed on the device prior to dialysis.Hand was utilized to tighten the adapters.Alcohol as per ifu (instruction for use) was the cleaning agent used on the device and to the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.It was said that there was a leak found on the product where the crack was observed but just tiny drops of blood and no blood transfusion was required.The patient did not require any medical intervention/treatment due to the cracks on the luer adapter.The patient did not experience any symptoms/harms as a result of the cracked luer adapter.It was noted that the dialysis treatment was resumed and completed after the catheter was repaired using a repair kit as remedial action to resolve the issue.It was said that the patient died and the caused of death was due to other circumstances, not a product failure and unrelated to the incident.
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Search Alerts/Recalls
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