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

Model Number	8888412015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2019
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, during use, a rupture occurred at the connection between the peritoneal tube and the external joint.It was reported that there was a leak at the junction of the extension tube and bifurcate which is also the catheter's shaft.The doctor had cut-off the broken part considering that the patient is still using the abdominal tube.Intervention was done by letting the rest of the catheter part be used normally, avoiding the damage caused to the patient by tube drawing and re-drawing.It was stated that this treatment method is also a common treatment method at present.The catheter was being cleaned without using of detergent and ointment but with usage of sterile gauzes.The patient is also responsible for the catheter maintenance like cleaning, dressing changes, etc.It was stated that there was no patient injury.

• 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: 8304756
• Report Number: 3009211636-2019-00021
• Device Sequence Number: 1063825
• Product Code: FJS
• UDI-Device Identifier: 10884521055490
• UDI-Public: 10884521055490
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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: 8888412015
• Device Catalogue Number: 8888412015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR