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

Model Number	8888423103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	07/03/2023
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
According to the reporter, the patient needed peritoneal dialysis due to chronic renal insufficiency and uremia.On (b)(6) 2021, after the pd (peritoneal dialysis) catheter was implanted in the nephrology department of the hospital, regular pd treatment was performed.Today, when the patient was performing normal peritoneal dialysis fluid replacement at home, it was found that the dialysis catheter was leaking liquid.A careful observation revealed that the pd catheter was ruptured and the dialysis catheter was clamped immediately with a clip.After 20 minutes, the patient came to the hospital for consultation.The doctor found that there was leakage on the upper end of the titanium connector which was a leakage of the dialysis tube.The leaking part was cut off, disinfected for half an hour and the titanium connector was reconnected.After connected and disinfected for half an hour, the external short tube was connected, it could be used normally and the issue was resolved.It was also mentioned that personal hygiene was not observed after the dialysis tube was broken.There was no connector issue and normal saline was the cleaning agent used to clean the catheter and its entirety.Flushing was performed.Formal manufacturer dressing was the wound dressing utilized.The cleaning agents were never mixed.The protocol was not changed for the cleaning agent used recently.The patient used a normal saline to clean the catheter.On (b)(6) (or two days after), the patient had abdominal pain and found that the peritoneal dialysis fluid was cloudy, etc., so the patient came to the nephrology department for treatment and the patient was found to have peritonitis which was an abdominal infection.It was stated that the leakage caused the patient's infection.Anti-infective treatment was given immediately and the patient was currently in treatment.The event led to patient's hospitalization for 2 weeks.There was no blood loss and blood transfusion was not required.The patient was in stable condition.

• Brand Name: ARGYLE
• Common Device Name: 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: 17430561
• Report Number: 3009211636-2023-00219
• Device Sequence Number: 7153470
• Product Code: FJS
• UDI-Device Identifier: 10884521055933
• UDI-Public: 10884521055933
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2025
• Device Model Number: 8888423103
• Device Catalogue Number: 8888423103
• Device Lot Number: 2023300196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 07/31/2023
• Date Device Manufactured: 11/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female