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

Model Number	8811313015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2018
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, during use, the patient noticed that the dressing of his peritoneal dialysis catheter was wet.He immediately drove to the hospital where a hole in the catheter tube was diagnosed shortly after the exit site.Prophylactic antibiotics were given to prevent peritonitis.Laparotomic procedure was done to replace the peritoneal catheter.It was stated that catheter was fixed with fixomull and the patient was not responsible for the catheter maintenance as his practice cleans the exit site three times a week with aqueous wound and mucous membrane antiseptic and was fixed with a gut belt.A customer reported there was no wound when the patient arrived at the hospital with the leaked catheter.There was only an exit site, which was covered with sterile compresses when not used.These compresses have been always dry and no ointment was used.The patient recovered after surgical intervention and was discharged from the hospital.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted that the device was received submerged in a formaldehyde solution.It was observed that the cuffs were coated pink, after neutralizing and disposing of the solution.The catheter was severed at the distal end.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the severed tip of the catheter may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• 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: 8039134
• Report Number: 3009211636-2018-00346
• Device Sequence Number: 1525644
• Product Code: FJS
• UDI-Device Identifier: 10884521004115
• UDI-Public: 10884521004115
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K890288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2019

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: 8811313015
• Device Catalogue Number: 8811313015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/08/2018; 12/13/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/03/2018; 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 55