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Model Number 8888135191 |
Device Problems
Migration or Expulsion of Device (1395); Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2021 |
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, a central venous catheter for hemodialysis was placed in the right femoral vein.At 11:30 on june 1, during hemodiafiltration dialysis treatment, the catheter was found to have slipped and the fixed sheath fell off (the suture wings were detached from the catheter), and the central venous catheter could not be fixed.The hemodiafiltration treatment was forced to end.It was also stated that they replaced the dialysis catheter or implant a double-lumen catheter as the medical intervention done to the patient, the treatment was proceeded and completed.The device was successfully used after it was replaced, there was a blood loss and blood transfusion was not required.Nothing unusual was observed on the device prior to use, flushing was performed with no problem result and there was no other product utilized with the device.There was no other defects/damages found on the product, the blood of the patient was safely returned, there was no luer adapter issue, tego was not utilized, and there was no cleaning agent used on the device.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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Manufacturer Narrative
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Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but photos were available for evaluation.The images showed the catheter being used on a patient.The last image showed the detached suture wing.It was reported that there was an ingrowth or catheter migration issue and there was a securement wing issue.The reported issues were 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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