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Model Number 8888135241 |
Device Problems
Material Puncture/Hole (1504); Product Quality Problem (1506)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 dual lumen catheter insertion into the right femoral vein for bedside continuous renal replacement therapy (crrt) after the patient had undergone dissection due to pregnancy with acute renal failure, there was also a crack noted in the venous line (about 3 mm where the hose overlaps the blue connector) after the clamp was pushed forward to clamp the hose and excessive force was not used.It was stated that the clamp was located between the hose and the end of the heparin cap and the device was not roughly clamped.It was confirmed that the clamp was not moved regularly.There was found to be leakage in the luer connector but it was noted that the heparin solution was sealed.The machine showed a high transmembrane pressure (tmp).The filter tube was pulled out and pressed, and the puncture site was observed for bleeding.It was also noted that the filter tube was sealed with heparin solution.There was nothing unusual observed on the device prior to use.The catheter was not repaired, tego was not utilized, and there were no cracks or other issues observed with the luer connector, teco additives were not used, and the insertion site was not treated prior to insertion.Iodofluoro was the cleaning agent used on the device.There was no eventual blood loss and blood transfusion was not performed.The inosine index of the patient was in normal range and no catheterization (treatment) was performed.There was no patient injury.
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Manufacturer Narrative
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H3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.Additionally a photograph of the device was also received.The visual inspection of the returned photo noted: the image depicts a crack at the connection of the blue adapter and extension tube.The visual inspection of the returned product noted: the extension tube at the blue luer adapter was cracked.The extension tube on the red luer adapter side was filled with blood.The cannula, hub and clamps appeared intact.A functional evaluation found that the distal end of the cannula was clamped and a water bath test was performed, no air bubbles were detected at the connection of the extension tube on the red port side.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the crack in the extension tube may occur when contact is made with a sharp surgical instrument during clinical application.The root cause of the observed damage was due to the product not being used as indicated which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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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