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

Model Number	8888145017
Medical Device Problem Code	Material Puncture/Hole (1504)
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
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during dialysis session, leakage was observed from the cut at junction of arterial extension tube and bifurcate.The clamp was moved periodically.Nothing unusual observed prior to use.Flushing was done successfully.No other products being utilized with the device.There was no damage to the device¿s box or packaging.The product was still sealed upon receipt.Betadine was the cleaning agent used on the device and it was used to treat the insertion site prior to product placement.Chlorhexidine was the cleaning agent typically utilized to clean the adapters.The cleaning agents were allowed to dry thoroughly prior to applying ointment to the area.The catheter was not repaired, no tego utilized, and no luer adapter issue.There was 5ml of blood loss.Blood transfusion was not required.No other intervention/treatment required as a result of the leakage.No medical intervention required to the patient.The catheter was removed and replaced with another product with the same type on the same day.The dialysis was successfully completed.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: 11249888
• Report Number: 3009211636-2021-00029
• Device Sequence Number: 3502234
• Product Code: MSD
• UDI-Device Identifier: 10884521013193
• UDI-Public: 10884521013193
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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: 08/14/2023
• Device Model Number: 8888145017
• Device Catalogue Number: 8888145017
• Device Lot Number: 1825400104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2021
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1