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

Model Number	8888123409
Medical Device Problem Codes	Defective Component (2292); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted no abnormalities.When the stylet was inserted into the luer adaptors, abnormal resistance was noted.It was reported that there was an issue with the catheter dimension.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, pre-operatively, the catheters' lumens were too narrow for stylets to be passed.The catheters were not repaired and there was no leak.There was no cleaning agent used on the devices.Tego was not utilized and there was no luer adapter issue.There was no damage to the devices' box and packaging.There was nothing unusual observed on the devices prior to use and flushing was done and had no issues in lumen with saline.There were no other products being utilized with the devices and no other defects/damages found on the products.The dimensions of the catheters matched what was indicated on the labels and the stylet used was the one included in each kits.The catheter was still used, but they had to use a stiffening guide wire instead of the stylets to insert the catheter and the procedure was completed.The physician was also aware that if the lumen was too narrow for the stylet, the volume of blood flow rates would be decreased.This eventually resulted in catheter failure and needed a new catheter to be inserted altogether at a later date (within 6 weeks).They decided to pull every catheter they believed were affected by the manufacturing issue off the shelf in this account to satisfy/appease the physicians and staff.There was no blood loss and blood transfusion was not required.There was no intervention/treatment required as a result of the event.There was no patient injury.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 11830139
• Report Number: 3009211636-2021-00108
• Device Sequence Number: 17085488
• Product Code: MSD
• UDI-Device Identifier: 10884521012967
• UDI-Public: 10884521012967
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K112477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2021

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: 12/17/2022
• Device Model Number: 8888123409
• Device Catalogue Number: 8888123409
• Device Lot Number: 2000700062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1