MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORP. VANTEX CVC WITH OLIGON MATERIAL; CENTRAL VENOUS CATHETER

Model Number ECVC3475

Device Problem Partial Blockage (1065)

Patient Problem No Information (3190)

Event Date 05/24/2016

Event Type  malfunction  

Event Description

In preparation for catheter insertion, staff were attempting to flush the triple lumens of a central venous catheter and were unable to do so.After 5 separate catheter kits were tried and all were blocked to one degree or another, staff examined the end of the catheter and identified two teal cylindrical pieces of plastic approximately 1/4" long, one with a small piece of clear plastic attached and the other with the clear plastic piece separated from the teal piece.These teal pieces are the same color as the hub for the triple lumens.Both the medial and proximal lumens were blocked to some degree.These small pieces presented a serious patient safety issue and these catheters pulled from use and marked do not use.The next day, the decision was made to pull all of the manufacturer's catheters as a precaution and supply chain ordered replacement arrow catheters to use in the meantime.

• Brand Name: VANTEX CVC WITH OLIGON MATERIAL
• Type of Device: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORP.; williamston MI 48895
• MDR Report Key: 5694249
• MDR Text Key: 46570601
• Report Number: MW5062582
• Device Sequence Number: 0
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: ECVC3475
• Device Lot Number: 2016032250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1