MAUDE Adverse Event Report: COVIDIEN LLC ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number 8888423111

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2024

Event Type  malfunction  

Event Description

According to the reporter, during assisted peritoneal dialysis, after connecting the tube, the tube was broken and water leakage was found.There was nothing unusual observe on the device prior to use and there were no other defects/damages found on the product where the leak was observed.Flushing was done with normal result.The leaking part of the catheter was cut off and reconnected for temporary use as remedial action and intervention/treatment provided as a result of the leaking.The product was not replaced.However, the external part was short and will need another surgery to replace the tube.The patient was not responsible for any type of catheter maintenance.Patient was not using any type of cleaning agent or antibiotic on the catheters.There was no blood transfusion required.There was no reported patient outcome.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, during assisted peritoneal dialysis, after connecting the tube, the tube was broken and water leakage was found.It was stated that the patient had peritonitis before surgery and continued to receive treatment after surgery.There was nothing unusual observed on the device prior to use and there were no other defects/damages found on the product where the leak was observed.Flushing was done with normal result.The leaking part of the catheter was cut off and reconnected for temporary use as remedial action and intervention/treatment provided as a result of the leaking.The product was not replaced.However, the external part was short and will need another surgery to replace the tube.The patient was not responsible for any type of catheter maintenance.Patient was not using any type of cleaning agent or antibiotic on the catheters.There was no blood transfusion required.The patient was undergoing treatment and in stable condition.There was no reported patient injury.

• Brand Name: ARGYLE
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18963465
• MDR Text Key: 338485646
• Report Number: 1000312731-2024-00006
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521056862
• UDI-Public: 10884521056862
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888423111
• Device Catalogue Number: 8888423111
• Device Lot Number: 2227200143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2024
• Date Device Manufactured: 10/09/2022
• 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