MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145016P
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2018
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 dialysis, the device had a pin hole in the venous limb of the silicone extensions.There was a blood leak noticed at the start of the treatment.The catheter had been in placed in the left femoral vein for 81 days.It was reported that the dialysis was discontinued and a new catheter was inserted.There was no patient injury reported and the patient is stable.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7400653
• Report Number: 3009211636-2018-00110
• Device Sequence Number: 1393656
• Product Code: MSD
• UDI-Device Identifier: 10884521157996
• UDI-Public: 10884521157996
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

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 Expiration Date: 08/11/2020
• Device Model Number: 8888145016P
• Device Catalogue Number: 8888145016P
• Device Lot Number: 1525200102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR