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

Model Number	8888119364P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
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 hd (hemodialysis) treatment, the catheter cracked.It was stated that a crack of less than 2mm was noted in the lumen between the hub and the ports (clear part under the clamps) and caused leaks of blood during flushing.In order to resolve the issue, a new catheter was used.It was also stated that chlorhexadine with alcohol swabs was the cleaning solution used on the catheter and no ointment was used.There was no patient injury.
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 hd (hemodialysis) treatment, the catheter had a crack.It was stated that a crack of less than 2mm was noted in the lumen between the hub and the ports (clear part under the clamps) and caused leaking of blood during flushing, and there was blood loss of 1-2ml and no transfusion was required.It was reported that the clamps are usually moved to a new location after each treatment.The catheter has been in place for 5 days.In order to resolve the issue, a new catheter was used.It was also stated that chlorhexadine with alcohol swabs was the cleaning solution used on the catheter and no ointment was used.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
• MDR Report Key: 8300593
• Report Number: 3009211636-2019-00019
• Device Sequence Number: 16157968
• Product Code: MSD
• UDI-Device Identifier: 20884521157702
• UDI-Public: 20884521157702
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 08/22/2022
• Device Model Number: 8888119364P
• Device Catalogue Number: 8888119364P
• Device Lot Number: 1726500094
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/03/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR