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

Model Number	8888123408P
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2017
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, there was found to be some bubbles forming between the catheter and the coating.It was stated that there was also peeling noted on the device.The cleaning agent used on the device was chlorhexidine with dry gauze dressing and bactroban.The catheter was monitored to ensure that there were no leaks or other issues.There was no patient injury.
Additional Manufacturer Narrative
H3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.The first photo depicts the catheter inserted into a patient.The nodules on the silver sleeve are a normal part of the function of the device when the silver has been dissolved.The second photo depicts the catheter inserted into a patient.The nodules on the silver sleeve are a normal part of the function of the device when the silver has been dissolved.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Our investigation was unable to determine a root cause or establish a relationship between the devices and the reported incident.No enhancements or improvements were generated for the reported condition.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 8689848
• Report Number: 3009211636-2019-00140
• Device Sequence Number: 19426281
• Product Code: MSD
• UDI-Device Identifier: 10884521157798
• UDI-Public: 10884521157798
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: 04/10/2018
• Device Model Number: 8888123408P
• Device Catalogue Number: 8888123408P
• Device Lot Number: 1512400098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 78