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

Model Number	8888145016
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
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, the guidewire was trapped inside the puncture needle and deforming was observed.The needle was needed to be removed and required a new venipuncture.They replaced the catheter as the intervention/treatment required as the result of the event and to resolve the issue.The procedure was completed, there was no blood loss, and blood transfusion was not required.Nothing unusual was observed on the device prior to use, there were no other defects/damages found on the device, there was no damage to the catheter itself, and there was no medical intervention done to the patient.The catheter was not repaired, there was no leak, tego was not utilized, and there was no luer adapter issue.It was also stated that there were no patient symptoms or complications associated with this event, there was no medical or surgical intervention needed to prevent a permanent impairment of a function, and the event did not lead to or extend patient hospitalization.There was no reported 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: 12589651
• Report Number: 3009211636-2021-00278
• Device Sequence Number: 3431478
• Product Code: MSD
• UDI-Device Identifier: 10884521013179
• UDI-Public: 10884521013179
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: 02/10/2023
• Device Model Number: 8888145016
• Device Catalogue Number: 8888145016
• Device Lot Number: 1806600081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1