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

Model Number	8888541028
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
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, there were leakage and fissure at the blue connector of the palindrome.
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, there was a leakage and fissure at the blue connector of the catheter.It was stated that a tego was utilized and the adapter was tightened by hand.The old connector was removed and a repair kit was utilized due to the issue.Octenisept was used as a cleaning agent to clean the adapter and the cleaning agent was allowed to dry thoroughly prior to applying ointments to the area.There was no patient injury.
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, there was a leakage and fissure at the blue connector of the catheter.It was stated that a tego was utilized and the adapter was tightened by hand.The old connector was removed and the connector from a new kit was utilized due to the issue.Octenisept was used as a cleaning agent to clean the adapter and the cleaning agent was allowed to dry thoroughly prior to applying ointments to the area.There was no patient injury.

• 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: 7991980
• Report Number: 3009211636-2018-00338
• Device Sequence Number: 16515937
• Product Code: MSD
• UDI-Device Identifier: 10884521135499
• UDI-Public: 10884521135499
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K111817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2018

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: 09/30/2020
• Device Model Number: 8888541028
• Device Catalogue Number: 8888541028
• Device Lot Number: 1429900067
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 11/09/2018; 11/27/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/02/2018; 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 92