|
Model Number 8888415604 |
Device Problem
Connection Problem (2900)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/18/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
According to the reporter, it was said that it was impossible to screw the cap on the adapter all the way despite several attempts by two different people.There was no reported patient outcome.
|
|
Manufacturer Narrative
|
Additional information: b5, g3 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.
|
|
Event Description
|
According to the reporter, it was said that it was impossible to screw the cap on the titanium adapter all the way despite several attempts by two different people using their hands.It was said that this happened when they changed the titanium adapter and cap on the catheter which they do every 6 months (not during dialysis).It was also said that there was no adapter issue or visible defects noted.No visible damage/defects noted on the cap.The device was not placed/installed since they were unable to screw the two parts together.Nothing unusual was observed on the device prior to use.No damage was noted on the device packaging and the box that the device came in was intact.No other products were being utilized with the device.The device was not repaired.There was no leak since the screw did not fit.It was said that the cleaning agent used was betadine as usual.Tego was not utilized.No other products were being utilized with the device.There was no blood loss and no blood transfusion was required.The patient had no medical intervention/treatment due to the event.It was said that they did not managed to use the titanium adapter and cap, and another titanium adapter and cap of same lot was used to resolve the issue.There was no reported patient injury.
|
|
Manufacturer Narrative
|
Additional info: b5, g3, h6 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.
|
|
Event Description
|
According to the reporter, it was said that it was impossible to screw the cap on the adapter (made of titanium) all the way despite several attempts by two different people using their hands.It was said that they did not observe anything abnormal on the adapter.This device was used when they adapted the extenders to the peritoneal dialysis catheter that they change every 6 months.The device was not placed/installed since they were unable to screw the two parts together.No visible damage to the cap.Nothing unusual was observed on the device prior to use.The package was not damaged and was said to be intact.No other products were used with the device.The device was not repaired.There was no leak since they were unable to screw it.It was said that the cleaning agent used was dermal betadine which they used every time they used this material.Tego (bidirectional valve obturator) was not utilized.No other products were being utilized with the device.There was no blood loss and no blood transfusion was required.The patient had no medical intervention due to the event.It was said that they used another titanium connector (same batch and manufacturer).There was no reported patient injury.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
According to the reporter, it was said that it was impossible to screw the cap on the titanium adapter all the way despite several attempts by two different people using their hands.It was said that this happened when they changed the titanium adapter and cap on the catheter which they do every 6 months (not during dialysis).It was also said that there was no adapter issue or visible defects noted.No visible damage/defects noted on the cap.The device was not placed/installed since they were unable to screw the two parts together.Nothing unusual was observed on the device prior to use.No damage was noted on the device packaging and the box that the device came in was intact.No other products were being utilized with the device.The device was not repaired.There was no leak since the screw did not fit.It was said that the cleaning agent used was betadine as usual.Tego was not utilized.There was no blood loss and no blood transfusion was required.The patient had no medical intervention/treatment due to the event.It was said that they did not managed to use the titanium adapter and cap, and another titanium adapter and cap of same lot was used to resolve the issue.There was no reported patient injury.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|