MAUDE Adverse Event Report: COVIDIEN LLC PALINDROME CATHETER KIT; CATHETER, HEMODIALYSIS, IMPLANTED

Lot Number 1533900046

Device Problem Split (2537)

Patient Problem No Information (3190)

Event Date 05/31/2017

Event Type  malfunction  

Event Description

An ash split dialysis cath was in left internal jugular.The cath has 3 dilators and the tip of one of the catheters broke off during use.

• Brand Name: PALINDROME CATHETER KIT
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 6646229
• MDR Text Key: 77719567
• Report Number: 6646229
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Lot Number: 1533900046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR