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

Model Number	8888145048
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2018
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, the device had a leak at the upper part of the venous hub that connects to the dialyze line.It was stated that, at the start of the patient's dialysis session, a small central venous catheter disruption in the upper part of the venous hub occurred.They immediately interrupted the dialysis in an interval of less than 30 seconds.Upon observing, together with the doctor on call they decided to put a titanium adapter so that the patient could at least dialyze until vascular evaluation for probable exchange.The catheter was changed after the dialysis was completed.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic 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.Appropriate.If information is provided in the future, a supplemental report will be issued.

• 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: 8065443
• Report Number: 3009211636-2018-00350
• Device Sequence Number: 1911962
• Product Code: MSD
• UDI-Device Identifier: 20884521013275
• UDI-Public: 20884521013275
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 8888145048
• Device Catalogue Number: 8888145048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 60