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Model Number 8888145015 |
Device Problems
Break (1069); Material Puncture/Hole (1504)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/09/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, while the patient was having dialysis, the catheter looked like there was bubbling and a leak coming from the venous port.The catheter was not repaired.The patient was rewired the next day.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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Event Description
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According to the reporter, 6 weeks after insertion, while the patient was having dialysis, the catheter looked like there was bubbling on the venous lumen extension tube.The catheter was not repaired.Nothing unusual was observed on the device prior to use.Flushing was done prior to use, and nothing unusual was noted.Chlorhexidine and alcohol swabs were cleaning agents used on the device and were typically utilized to clean the adapters.It was uncertain if the cleaning agents were allowed to dry thoroughly prior to applying ointment to the area; however, the policy was to allow an appropriate drying time.They did not tighten the adapters.They put a tego on the end and ensured they were on securely.The policy was to move the qrun clamps.No other products were being utilized with the device.No other defects or damages were found.The patient was rewired urgently the next day with a 19-centimeter-brand tcc (tunneled cuffed catheters) and a different lot, and the treatment was completed.There was a small amount of blood loss.A blood transfusion was not required.The patient had no air embolism due to the event.There was no reported patient injury.
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Manufacturer Narrative
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Additional information: b5, e1 (first name, last name, fax number, phone number), e2, e3, g3, h6 (ime, imf, fdd) 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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