MAUDE Adverse Event Report: BAXTER ONE-LINK NEEDLE-FREE IV CONNECTOR

Model Number 7N8399

Device Problems Split (2537); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/30/2015

Event Type  Injury  

Event Description

Collodion remover (mavidon) was used to remove eeg from this infant who was ecmo after open heart surgery.Shortly thereafter the pt bled from the right internal jugular central line.The baxter one-link needle free connector was found to be split, cloudy, mis-shapen and leaking.The cap was replaced and the bleeding stopped.Another connector was exposed to be collodion remover in-vitro and reacted the same way.Reason for use: to remove eeg leads.

• Brand Name: ONE-LINK NEEDLE-FREE IV CONNECTOR
• Type of Device: ONE-LINK NEEDLE-FREE IV CONNECTOR
• Manufacturer (Section D): BAXTER; deerfield IL 60015
• MDR Report Key: 4771536
• MDR Text Key: 22252311
• Report Number: MW5042679
• Device Sequence Number: 2
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7N8399
• Device Lot Number: 07-36-71-510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO
• Patient Weight: 5