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	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection noted: the photograph depicts the blue and red ports with a syringe attached to the red port.The yellow caps are on the lumen.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, blood leak was noted coming from the connection of the arterial (red) connector and the extension tube.Then after a few weeks, while checking for permeability of the catheter, the venous (blue) had the same issue.It was stated that the connector was changed with the repair kit, distal connectors were changed and iv antibiotics was given as an intervention.It was stated that catheter was 1 year old.There was no reported 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 treatment, blood leak was noted coming from the connection of the arterial (red) connector and the extension tube.Then after a few weeks, while checking for permeability of the catheter, the venous (blue) had the same issue.It was stated that the connector was changed with the bard repair kit, distal connectors were changed and iv antibiotics was given as an intervention, chlorhexidine 2% alcohol 70 % was the cleaning agent used and tego adapter was the method used to tighten the adapters.It was stated that there was no significant blood loss due to the event.It was stated that catheter was 1 year old.There was no patient injury.

• 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: 8293455
• Report Number: 3009211636-2019-00015
• Device Sequence Number: 1332807
• 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): 03/15/2019

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: 04/24/2019
• Device Model Number: 8888145044P
• Device Catalogue Number: 8888145044P
• Device Lot Number: 1613900109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 91