MAUDE Adverse Event Report: COVIDIEN PALINDROME CHRONIC CATHETER 10 SIZE, 14.5 FR/19CM; DIALYSIS TUNNELED CATHETER

Model Number PALINDROME SPORT PAK

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2017

Event Type  malfunction  

Event Description

Pt has a covidien palindrome chronic catheter sport pak ref # 8888119365 7, lot: 15194009 which was inserted on (b)(6) 2016.On (b)(6) 2017 hemodialysis treatment was started with a blood flow rate of 400 per order.Both arterial and venous pressures were within normal limits.Foam was noted at both arterial and venous chambers.Upon closer investigation it was noted that air bubbles were coming directly from the arterial lumen.Treatment was terminated, patient to interventional radiology for procedure to have catheter replaced.

• Brand Name: PALINDROME CHRONIC CATHETER 10 SIZE, 14.5 FR/19CM
• Type of Device: DIALYSIS TUNNELED CATHETER
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6431534
• MDR Text Key: 70933800
• Report Number: MW5068637
• Device Sequence Number: 1
• Product Code: MSD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2018
• Device Model Number: PALINDROME SPORT PAK
• Device Catalogue Number: 8888119365
• Device Lot Number: 151940090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 93