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

Model Number 8888425710

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Consequences Or Impact To Patient (2199); Peritonitis (2252)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, on (b)(6), a small bend with a hole in the tunnel area between two sleeves was noted and a leak was found next to the cuff.The catheter was explanted from the left side and a new catheter was implanted on the right and the treatment for the peritonitis continued till (b)(6) 2020.The patient was trained to change the bandages 2-3 days (after showering) dry using normal wound compresses ¿cutisoft¿( 100% cotton 7.5cm x 7.5cm) or with 0.9% nacl then octenisept alcohol-free or gentamycin eye drops locally as the cleaning agents used every day if there are infections.The cleaning agent was allowed to dry thoroughly prior to applying ointment and dressing the area.The cleaning agent was not switched over the life of the life of the catheter and was not mixed.No "sepsiderm" was used.The catheter was not repaired, no tego utilized, no other products being utilized with the device and no luer adapter issue.There was no blood loss and no blood transfusion required.The patient was currently stable.

Manufacturer Narrative

2020-09-24, mandar8 correction.This event including all the pertinent information has been documented under rr# 257484342.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
• MDR Report Key: 10577559
• MDR Text Key: 208299473
• Report Number: 3009211636-2020-00237
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521056022
• UDI-Public: 10884521056022
• Combination Product (y/n): N
• PMA/PMN Number: K813488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2022
• Device Model Number: 8888425710
• Device Catalogue Number: 8888425710
• Device Lot Number: 1717200122
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 60 YR
• Patient Weight: 76