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

Model Number 8888145044

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, prior to insertion, the stylets were blocked, it could not fit/go through the catheter but no visible defect/damage noted.Flushing was done prior to use and the result was the same that occurred on stylet, it did not feed or go through the catheter.The catheter could not be used.A new catheter was opened and used to resolve the issue.It was stated that the procedure was completed.Heparin sauve was the cleaning agent used on the device.There was no blood loss and no intervention/treatment required.The stylets that was used were the ones included in the kit.There was no problem with the catheter's dimension.There were no other products being utilized with the device.There was no packaging damage.There was no patient injury.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that the device was occluded.The device was available for evaluation.Visual inspection noted the device had a cracked or broken y-hub.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.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
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 12275231
• MDR Text Key: 264991879
• Report Number: 3009211636-2021-00193
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521013247
• UDI-Public: 10884521013247
• Combination Product (y/n): N
• PMA/PMN Number: K112477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: 8888145044
• Device Catalogue Number: 8888145044
• Device Lot Number: 1933700119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1