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

Model Number	8888413815
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post laparoscopic installation of catheter in a filtration, when the patient changed position they noticed that the dressing became wet and there was a leak.They still continued with the therapy for several days because of filtration reasons.They tested the catheter and they certified that there was a fissure approximately 1 cm after the second cuff near the radiopaque line.They scheduled for another laparoscopic procedure to remove the catheter, and install a new one to resolve the case.

• 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
• MDR Report Key: 7452490
• Report Number: 3009211636-2018-00127
• Device Sequence Number: 13716153
• Product Code: FJS
• UDI-Device Identifier: 10884521004627
• UDI-Public: 10884521004627
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K862046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2021
• Device Model Number: 8888413815
• Device Catalogue Number: 8888413815
• Device Lot Number: 1620900134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR