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

Model Number	8888145057C
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: a device history review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.One picture was provided by the customer.Visual evaluation of this photo was performed; the image shows a catheter in use (inside the patient) and a portion of the am sleeve has bubbles or blistering.The reported condition was confirmed with the photo provided by the customer.The most probable root cause can be considered as that the customer used a different cleaning agent from recommended.No trends or triggers have been found.Therefore, a corrective or preventive action is not deemed necessary at this time.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, the color of the catheter has changed and bubbles were noticed.It was stated that the catheter works properly and the interventional radiologist did not want to replace it just because the bubbles were present.It was also stated that the patient's catheter insertion site was slightly flushed.
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
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7733456
• Report Number: 3009211636-2018-00257
• Device Sequence Number: 10964051
• Product Code: MSD
• UDI-Device Identifier: 10884521083073
• UDI-Public: 10884521083073
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 06/09/2018
• Device Model Number: 8888145057C
• Device Catalogue Number: 8888145057C
• Device Lot Number: 1518000125
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR