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Model Number 8888135191 |
Device Problem
Disconnection (1171)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/15/2022 |
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 patient's renal function was monitored, for elevated serum creatinine and low urine output.Bedside crrt (continuous renal replacement therapy) treatment was required.The doctor performed a right femoral vein catheterization under aseptic operation.During the indwelling process (during catheterization), the catheter suddenly broke/ruptured (broken in to two pieces-catheter shaft was detached from the bifurcate).It was stated that the catheter was not in use with a dialysis machine at the time of the reported event.There was no abnormal conditions noted with the device prior to the reported rupture and there was no visual abnormalities with the catheter prior to the reported event.There was nothing unusual observe on the device prior to use, flushing done prior to use with normal result, no other products was utilized with the device, no excessive force was used on the device, there was no cleaning agent used on the device, and sepsiderm was not use to clean the catheter.The doctor immediately removed the catheter, pressed the puncture point, and then selected another catheter to indwell successfully again (secondary surgical trauma).The catheter ruptured, increased patient distress and there was no infection due to the event.There was about 20-30ml of blood loss and blood transfusion was not required.The patient later died of other cause (death was not related to the event).
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Manufacturer Narrative
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Additional information: g1, g2, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted the catheter had broken at the connection of the cannula and the y-hub.It was reported that the catheter shaft disconnects from the hub/bifurcate.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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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