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

Model Number	8888541023P
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2020
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, after dialysis treatment, the nurse found a leak on the connection between silicone extension and connector of the extension tube (venous lumen).It was stated that treatment has been completed before the leakage was seen.There was nothing unusual observed on the device prior to use and there were no other products being utilized.Flushing was done with saline 0.9% and the results were normal.Tego was not utilized and no luer adapter issue.The catheter was repaired using the repair kit.Octenisept alcohol free was the cleaning agent used on the device and the adapters.The cleaning agents were allowed to dry thoroughly prior to ointment application in the area.Repeated clamping was not performed but the clamp moved periodically.There was no blood loss.There were no patient symptoms or complications.There was no other intervention done aside from using the repair kit.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Additionally photographs of the device were also received.A visual inspection of the returned photos noted: the first image depicts a gloved hand showing a cut in the extension tube on the bluer luer adapter side.The cut is in the area where the adapter and extension tube join together.The second image depicts a close-up view of the cut in the extension tube.A visual inspection of the returned product noted: cannula was disengaged from the hub and not received.The extension tube on the blue luer adapter side was cut.The cut is in the area where the adapter and extension tube join together.The red luer adapter and extension tube clamps appeared intact.A test guide wire was passed through both extensions without occlusion.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Replication of the cut in the extension tube may occur when contact is made with a sharp surgical instrument during clinical application.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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.

• 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: 9664899
• Report Number: 3009211636-2020-00033
• Device Sequence Number: 3135221
• Product Code: MSD
• UDI-Device Identifier: 10884521158504
• UDI-Public: 10884521158504
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 8888541023P
• Device Catalogue Number: 8888541023P
• Device Lot Number: 1906700185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 83