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

Model Number 8811313010

Device Problems Insufficient Flow or Under Infusion (2182); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the doctor reported problems in the functioning of the peritoneal catheters.It was stated that the tip or tail of the catheters moved from its place and out of the pelvic hollow, this did not allow good flow or remove all fluid from the peritoneal cavity.It was mentioned that there was no leak on one of the catheters (2113300312).There were no patient symptoms or complications associated with this event, no medical or surgical intervention was needed to prevent a permanent impairment of a function, and the event did not lead to or extend patient hospitalization.There was no reported patient injury.

• 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: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13840727
• MDR Text Key: 287575600
• Report Number: 3009211636-2022-00071
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521004085
• UDI-Public: 10884521004085
• Combination Product (y/n): N
• Reporter Country Code: GT
• PMA/PMN Number: K180485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8811313010
• Device Catalogue Number: 8811313010
• Device Lot Number: 2104900103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Date Device Manufactured: 03/02/2021
• 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