MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. ONE-LINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 7N8399

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

There was no device in three individual packages of baxter one-link needle-free iv connector.The packaging is completely sealed with only air and no actual device.Lot ur21c24033.

• Brand Name: ONE-LINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12525352
• MDR Text Key: 273112772
• Report Number: 12525352
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7N8399
• Device Catalogue Number: 7N8399
• Device Lot Number: UR21C24033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1