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 Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
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 peritoneal dialysis, the catheter was secured during external traction and getting without distal foam.The break of the catheter was found at the distal end(near the skin) which makes the catheter to burst and making its unfeasible.The procedure was completed but they had to extend the surgical time of 20 minutes due to the catheter replacement.The catheter was not repaired and there was no blood leak.Tego was not utilized and there was no luer adapter issue.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: 8829176
• Report Number: 3009211636-2019-00178
• Device Sequence Number: 2417182
• Product Code: FJS
• UDI-Device Identifier: 10884521004627
• UDI-Public: 10884521004627
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K862046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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 Expiration Date: 10/05/2021
• Device Model Number: 8888413815
• Device Catalogue Number: 8888413815
• Device Lot Number: 1630700085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR