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Model Number 8888145014 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2023 |
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, intraoperatively, when tunnel needle was inserted into patient, the tunnel needle separated/detached from the holder or fixator.The catheter was not repaired and there was no leak.Tego was not utilized and there was no luer adapter issue.The insertion site was not treated prior to product placement.There was no cleaning agent used on the device.There was nothing unusual observed on the device, no other damages were found on the product, no other products were utilized with the device and flushing was done with normal result.No excessive force was used on the product.The tunneler used was the one included in the kit.There were no broken pieces that fell into the patient's body and tunneler was fully retrievable.The whole kit will be returned and the product was replaced to resolve the issue.Procedure was completed.There was no blood loss and blood transfusion was not required.There was no intervention/medical treatment required as the result of the event.There was no reported patient injury.
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Manufacturer Narrative
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Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted one bent tunneler and the blue connector (also bent) was detached from the metal needle.It was presumed that the tunneler was initially undamaged as the device was used.It was reported that the tunneler broke apart.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur due to excessive force during use.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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