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

Model Number	8888145044P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
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 treatment, blood leak was noted coming from the distal junction of the venous branch.It was stated that there was a break at this place.Treatment was not initiated as there was a risk of air entering the leak and pulmonary embolism.The venous branch was repaired with the repair kit and a dose of antibiotics was given as an intervention.There was no reported patient injury.
Event or Problem Description
According to the reporter, during treatment, blood leak was noted coming from the distal junction of the venous branch.It was stated that tego adapter was used to tighten the adapters and the cleaning agent used was chlorhexidine 2% alcohol 70 %.It was stated that there was a break at this place.Treatment was not initiated as there was a risk of air entering the leak and pulmonary embolism.The venous branch was repaired with the repair kit and a dose of antibiotics was given as an intervention.It was also stated that it was a luer adapter issue as the small leak came from under the white rubber part.There was no significant blood loss due to theleak.There was no reported patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8293613
• Report Number: 3009211636-2019-00018
• Device Sequence Number: 13852861
• Product Code: NYU
• UDI-Device Identifier: 10884521158092
• UDI-Public: 10884521158092
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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 Expiration Date: 09/15/2019
• Device Model Number: 8888145044P
• Device Catalogue Number: 8888145044P
• Device Lot Number: 1628800104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1