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

Model Number	8888145042P
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2018
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 treatment, the flow in the dialysis line couldn't be taken.The a side and v side were reversely connected, but the bloody removal failed.The blood removal failure occurred in less than a week after the catheter was placed in the left femoral of the patient.It was stated that the catheter could be used for blood return, but it couldn't be used for blood removal, and the a side line was taken by dialysis needle.Flushing was performed prior to use and the device was flushed without problems.The catheter was replaced.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during treatment, the flow in the dialysis line couldn't be taken.The a side and v side were reversely connected, but the blood removal failed.The blood removal failure occurred in less than a week after the catheter was placed at the left femoral of the patient.It was stated that the catheter could be used for blood return, but it couldn't be used for blood removal, and the a side line was taken by dialysis needle.Flushing was performed prior to use and the device was flushed without problems.The catheter was replaced.There was no reported 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: 8108057
• Report Number: 3009211636-2018-00374
• Device Sequence Number: 1827620
• Product Code: MSD
• UDI-Device Identifier: 20884521158051
• UDI-Public: 20884521158051
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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: 8888145042P
• Device Catalogue Number: 8888145042P
• Device Lot Number: 8888145042P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 11/03/2018
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1