MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER ONE-LINK NEEDLE FREE IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 7N8399

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2023

Event Type  malfunction  

Event Description

Iv connector just fell apart.

• Brand Name: BAXTER ONE-LINK NEEDLE FREE IV CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 16876886
• MDR Text Key: 314733724
• Report Number: MW5117257
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2023

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: Health Professional
• Device Model Number: 7N8399
• Device Catalogue Number: 7N8399
• Device Lot Number: UR22F03123
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1