MAUDE Adverse Event Report: NIPPON COVIDIEN LIMITED PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888541023
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2019
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, they found the device leaking and was broken below the y-piece, it was also stated that there was a blood loss.Nothing unusual observed before use and the product was explanted, a new acute catheter was implanted to continue procedure.There was no reported patient injury.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): NIPPON COVIDIEN LIMITED; 1217-1 tomonaga, fukuro; fukuroi; alajuela 437-0 004
• MDR Report Key: 8977998
• Report Number: 3009211636-2019-00198
• Device Sequence Number: 16859874
• Product Code: MSD
• UDI-Device Identifier: 10884521135482
• UDI-Public: 10884521135482
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111817
• 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): 09/09/2019

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: 8888541023
• Device Catalogue Number: 8888541023
• Device Lot Number: 1804000123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 90