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

Model Number	8888411405
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
According to the reporter, the nurse stated that the patient had a catheter implanted on (b)(6) 2024.After the catheter was implanted, the injection was smooth but the drainage was not smooth so the patient was admitted to the hospital, but it never improved.The catheter was not repaired.No cleaning agent used on the device.There was no luer adapter issue.The site never used sepsiderm to clean catheter.No ointment(s) utilized at the exit site.No wound dressing(s) utilized.No treatment (lotions/ointments, medications) by prescription or over-the-counter (otc) used.
Additional Manufacturer Narrative
Additional information: b5, g3 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.
Event or Problem Description
According to the reporter, the nurse stated that the patient had a catheter implanted on (b)(6) 2024.After the catheter was implanted, during operation after line connection, the injection was smooth but the drainage was not smooth and there was inadequate drainage so the patient was admitted to the hospital, but it never improved.The therapy was not completed.The catheter was not repaired.No cleaning agent used on the device.There was no luer adapter issue.The site never used sepsiderm to clean catheter.No ointment(s) utilized at the exit site.No wound dressing(s) utilized.No treatment (lotions/ointments, medications) by prescription or over-the-counter (otc) used.Nothing else unusual observed on the device prior to use.Flushing/priming done prior to use and the result had no problem.No other products being utilized with the device.No other defects/damages found on the product.The line was not hard to flush with the syringe.There was no blood return prior to syringe flush.No anti coagulation (tpa, heparin) used.No remedial action performed to address the issue.There was no blood loss.Blood transfusion was not required.No other medical intervention/treatment required as a result of the event.
Event or Problem Description
According to the reporter, the nurse stated that the patient had a catheter implanted on (b)(6) 2024.After the catheter was implanted, during operation after line connection, the injection was smooth but the drainage was not smooth and there was inadequate drainage so the patient was admitted to the hospital, but it never improved.The therapy was not completed.The catheter was not repaired.No cleaning agent used on the device.There was no luer adapter issue.The site never used sepsiderm to clean catheter.No ointment(s) utilized at the exit site.No wound dressing(s) utilized.No treatment (lotions/ointments, medications) by prescription or over-the-counter (otc) used.Nothing else unusual observed on the device prior to use.Flushing/priming done prior to use and the result had no problem.No other products being utilized with the device.No other defects/damages found on the product.The line was not hard to flush with the syringe.There was no blood return prior to syringe flush.No anti coagulation (tpa, heparin) used.No remedial action performed to address the issue.There was no blood loss.Blood transfusion was not required.No other medical intervention/treatment required as a result of the event.The patient's status after the event was in good condition.
Additional 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.

• Brand Name: ARGYLE
• Common Device Name: 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: 19571052
• Report Number: 1282497-2024-00177
• Device Sequence Number: 8470377
• Product Code: FJS
• UDI-Device Identifier: 10884521054974
• UDI-Public: 10884521054974
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K180485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2024

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: 09/17/2025
• Device Model Number: 8888411405
• Device Catalogue Number: 8888411405
• Device Lot Number: 2026000137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 06/21/2024; 07/11/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 06/27/2024; 07/30/2024
• Date Device Manufactured: 11/18/2020
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian