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Model Number 8888145014 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
Event Type
malfunction
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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, the tunneled cuffed catheter (tcc) was placed on the patient in (b)(6) 2023 respectively.After eight months of use, the catheter arterial tubing cap fitting (external connector) was ruptured or cracked, and there was a blood leakage from the external connector wall at the start of the treatment.Flushing was not done prior to use.It was not done with an hrf filter, and tego was not utilized.There was no excessive force used on the device.The adapters were tightened by hand.There was no cleaning agent used on the device.The insertion site was not treated prior to product placement.As a medical treatment due to the event and as a remedial action, the ntc cap (short term tube) was used to replace the tcc breaker cap on the same day of the event.The treatment was completed.There was no blood loss, and a blood transfusion was not performed.Aside from ntc cap replacement, there was no other intervention/treatment required due to the event.There was no reported patient injury.
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Search Alerts/Recalls
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