COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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Model Number 8813793009 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2022 |
Event Type
malfunction
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Event Description
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According to the reporter, the patient had a catheter placement on (b)(6) 2022.After starting dialysis on (b)(6) 2022, it was noticed that a kink was already present at the skin entrance - arterial lumen, so just after the bifurcation triangle.After removal, it was seen that there was another kink further up, side venous lumen (those kinked parts that went into the patient were both on the arterial and venous sides).The catheter was not repaired.Nothing unusual was observed on the device prior to dialysis.There was no leak and no luer adapter issue.Tego was not utilized.The device was disinfected with cleaning agent chlorhexidine gluconas 2%, magis pharma and needed to apply fucidin ointment on the insertion site from day 1 to 14.The clamps were moved to a new location after each treatment.No other products were used with the device.There was no insufficient flow issue noted on the kinked arterial and venous sides as they were able to run at a blood flow rate of 300ml/g.There was no blood loss and no blood transfusion was required.Treatment was noted to be completed.It was said that the patient had a blood values check for hemolysis and the result was no hemolysis as the ldh (lactate dehydrogenase) and haptoglobin were both okay.To resolve the issue, the catheter was explanted and replaced with another catheter from the competitor on (b)(6) 2022.There was no reported patient injury.
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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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