MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number 8888423103

Device Problems Break (1069); Material Deformation (2976)

Patient Problem Unspecified Infection (1930)

Event Date 06/15/2023

Event Type  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.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, the patient underwent peritoneal dialysis catheterization in the hospital on (b)(6) 2021 due to renal insufficiency and uremia, and underwent long-term peritoneal dialysis treatment.On the morning of (b)(6) 2023, the patient found fluid leaking from the peritoneal dialysis tube at home.Three hours later, the patient was consulted by the nephrology department of the hospital and the doctor found that there was leakage at the upper end of the titanium joint which belonged to the leakage of the dialysis tube.The patient had a lot of peritoneal dialysate extravasation.It was also stated that the patient was not protected well at home and the peritoneal dialysis tube was kinked resulting in damage to the dialysis tube.There was no adapter issue and no excessive force applied to the device.Nothing unusual observed on the catheter prior to use.Flushing was performed with saline prior to use of the catheter.No crack, cut, or hole found on the catheter where the leak was observed.No other products being utilized with the catheter.No ointment utilized at the exit site.Formal manufacturer wound dressings was utilized.The wound dressings did not include any cleaning agents or antimicrobial properties.The cleaning agent was allowed to dry thoroughly prior to dressing the area.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.The patient was responsible for any type of catheter maintenance.The cleaning agent was never switched over the life of the catheter.The site never used sepsiderm to clean the catheter.There was no protocol change for cleaning agents used recently on the catheter.The patient did not use any type of cleaning agent or antibiotic on the catheter.They immediately clamped the dialysis tube with clip and cut off the leaking section.They sterilized it for half an hour, reconnected the titanium connector, then sterilized for half an hour after connecting, and connected the external short tube.The problem was resolved, the device could be used normally and the treatment was completed.No repair kit used.The patient did not experience immeasurable harm.The patient had abdominal infection and intervention/treatment was required for the infection.There was no blood loss and blood transfusion was not required.The patient had no vascular injury.The patient is currently in hospital treatment.

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, the patient underwent peritoneal dialysis catheterization in the hospital on (b)(6) 2021, due to renal insufficiency and uremia, and underwent long-term peritoneal dialysis treatment.On the morning of (b)(6) 2023, the patient found fluid leaking from the peritoneal dialysis tube at home.Three hours later, the patient was consulted by the nephrology department of the hospital, and the doctor found that there was leakage at the upper end of the titanium joint, which belonged to the leakage of the dialysis tube.The patient had a lot of peritoneal dialysate extravasation.It was also stated that the patient was not well protected at home and that the peritoneal dialysis tube was kinked, resulting in damage to the dialysis tube.There was no adapter issue.No excessive force was applied to the device.Nothing unusual was observed on the catheter prior to use.Flushing was performed with saline prior to the use of the catheter, and the result was normal.No crack, cut, or hole was found on the catheter where the leak was observed.No other products were being utilized with the catheter.Normal saline was the cleaning agent typically used to clean the entire catheter.Formal manufacturer wound dressings were utilized.The wound dressings did not include any cleaning agents or antimicrobial properties.The cleaning agent was allowed to dry thoroughly prior to dressing the area.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.The patient was responsible for any type of catheter maintenance.The cleaning agent was never switched over during the life of the catheter.The site never used sepsiderm to clean the catheter.There was no protocol change for cleaning agents used recently on the catheter.The patient did not use any type of cleaning agent or antibiotic on the catheter.They immediately clamped the dialysis tube with a clip and cut off the leaking section.They sterilized it for half an hour, reconnected the titanium connector, then sterilized it for half an hour after connecting the external short tube.The problem was resolved, the device could be used normally, and the treatment was completed.No repair kit was used.The patient had an abdominal infection, and intervention or treatment was required for the infection.No culture was taken.There was no blood loss, and a blood transfusion was not required.The patient had no vascular injuries.The patient was hospitalized due to the abdominal infection.The patient is currently receiving hospital treatment.The patient's current condition was good.

Event Description

According to the reporter, the patient underwent peritoneal dialysis catheterization in the hospital on (b)(6) 2021 due to renal insufficiency and uremia, and underwent long-term peritoneal dialysis treatment.On the morning of (b)(6) 2023, the patient found fluid leaking from the peritoneal dialysis tube at home.Three hours later, the patient was consulted by the nephrology department of the hospital and the doctor found that there was leakage at the upper end of the titanium joint, which belonged to the leakage of the dialysis tube.The patient had a lot of peritoneal dialysate extravasation.It was also stated that the patient was not protected well at home and the peritoneal dialysis tube was kinked resulting in damage to the dialysis tube.There was no adapter issue.No excessive force applied to the device.Nothing unusual observed on the catheter prior to use.Flushing was performed with saline prior to use of the catheter and the result was normal.No crack, cut, or hole found on the catheter where the leak observed.No other products being utilized with the catheter.Formal manufacturer wound dressings was utilized.The wound dressings did not include any cleaning agents or antimicrobial properties.The cleaning agent was allowed to dry thoroughly prior to dressing the area.The c leaning agent was allowed to dry thoroughly prior to applying ointment to the area.The patient was responsible for any type of catheter maintenance.The cleaning agent was never switched over the life of the catheter.The site never used sepsiderm to clean the catheter.There was no protocol change for cleaning agents used recently on the catheter.The patient did not use any type of cleaning agent or antibiotic on the catheter.They immediately clamped the dialysis tube with clip and cut off the leaking section.They sterilized it for half an hour, reconnected the titanium connector, then sterilized for half an hour after connecting, connected the external short tube.The problem was resolved, the device could be used normally and the treatment was completed.No repair kit used.The patient had abdominal infection and intervention/treatment was required for the infection.No cultures taken.There was no blood loss and blood transfusion was not required.The patient had no vascular injury.The patient is currently in hospital treatment.

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, the patient underwent peritoneal dialysis catheterization in the hospital on (b)(6) 2021, due to renal insufficiency and uremia, and underwent long-term peritoneal dialysis treatment.On the morning of (b)(6) 2023, the patient found fluid leaking from the peritoneal dialysis tube at home.Three hours later, the patient was consulted by the nephrology department of the hospital, and the doctor found that there was leakage at the upper end of the titanium joint, which belonged to the leakage of the dialysis tube.However, the company's product did not have joints, and the titanium joints were the other company products that the hospital was equipped with.The patient had a lot of peritoneal dialysate extravasation.It was also stated that the patient was not well protected at home and that the peritoneal dialysis tube was kinked, resulting in damage to the dialysis tube.No excessive force was applied to the device.Nothing unusual was observed on the catheter prior to use.Flushing was performed with saline prior to the use of the catheter, and the result was normal.No crack, cut, or hole was found on the catheter where the leak was observed.No other products were being utilized with the catheter.Normal saline was the cleaning agent typically used to clean the entire catheter.Formal manufacturer wound dressings were utilized.The wound dressings did not include any cleaning agents or antimicrobial properties.The cleaning agent was allowed to dry thoroughly prior to dressing the area.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.The patient was responsible for any type of catheter maintenance.The cleaning agent was never switched over during the life of the catheter.The site never used sepsiderm to clean the catheter.There was no protocol change for cleaning agents used recently on the catheter.The patient did not use any type of cleaning agent or antibiotic on the catheter.They immediately clamped the dialysis tube with a clip and cut off the leaking section.They sterilized it for half an hour, reconnected the titanium connector, then sterilized it for half an hour after connecting the external short tube.The problem was resolved, the device could be used normally, and the treatment was completed.No repair kit was used.The patient had an abdominal infection, and intervention or treatment was required for the infection.No culture was taken.There was no blood loss, and a blood transfusion was not required.The patient had no vascular injuries.The patient was hospitalized due to the abdominal infection.The patient is currently receiving hospital treatment.The patient's current condition was good.

Manufacturer Narrative

Additional information: b5, g3, h6 (removed secondary rfr code - adapter-leaking/cracked/broken).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.

• Brand Name: ARGYLE
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17301859
• MDR Text Key: 318924556
• Report Number: 3009211636-2023-00199
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521055933
• UDI-Public: 10884521055933
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K180485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888423103
• Device Catalogue Number: 8888423103
• Device Lot Number: 2026000156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2023
• Date Device Manufactured: 01/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female