MAUDE Adverse Event Report: COOK INC. CENTRAL CATHETER; CATHETER, INTRAVASCULAR

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/07/2018

Event Type  Injury  

Event Description

Right femoral line placed (b)(6) 2018 developed a leak on day four of use ((b)(6) 2018).Triple lumen 5fr 8cm catheter (manufactured by cook) with leak on blue port of line.This is the second time for this pt this failure mode had occurred, and similar product by the same mfr.This port is locked and out of use, however the line is still in placed as the other two ports are being used for cares.Not having the third port impacts, the care for this pt and may require the pt to have add'l access created.

• Brand Name: CENTRAL CATHETER
• Type of Device: CATHETER, INTRAVASCULAR
• Manufacturer (Section D): COOK INC.
• MDR Report Key: 7957307
• MDR Text Key: 123517863
• Report Number: MW5080495
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention