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

Model Number	8817278006
Medical Device Problem Codes	Material Discolored (1170); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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, the catheter is breaking down at the exit site and turning opaque.The catheter was inserted in 2012, and in (b)(6) 2015, they noticed the opaqueness and recently they started noticing the bubbling.It was stated that the catheter is still in use, and they expect that it will need to be removed shortly but this will be a medical decision.It was reported that the standard maintenance procedures include the patient showers are allowed, so dressings can be changed on average from daily to every other day.There is no direction provided to patients regarding the type of body cleaner or shampoo/conditioner and to use gentle antibacterial soap (looking into possible options for non-antibacterial).Patients can also clean the exit site with vitamin c flush following the shower with saline-based solution.Other options include applying on 3 antibiotic creams.A dressing should be applied once skin is dry and a 2x2 gauze dressing may be used over the top of cream, then the dressing is applied.There is no skin preparation or alcohol use to prepare skin for dressing adhesive.

• 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: 7490202
• Report Number: 3009211636-2018-00139
• Device Sequence Number: 1339766
• Product Code: FJS
• UDI-Device Identifier: 10884521004252
• UDI-Public: 10884521004252
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K890288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

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 Model Number: 8817278006
• Device Catalogue Number: 8817278006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1