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

Model Number 7N8301

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/30/2022

Event Type  malfunction  

Event Description

The nurse was attempting to draw blood utilizing the non-dehp standard bore catheter extension set and it would not draw blood.No patient harm occurred.

• Brand Name: ONE-LINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15334512
• MDR Text Key: 299046083
• Report Number: 15334512
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7N8301
• Device Catalogue Number: 7N8301
• Device Lot Number: (10)R22C16031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1