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

Model Number 7N8310

Device Problems Disconnection (1171); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 02/20/2023

Event Type  malfunction  

Event Description

During routine safety check, i found the patient's t-piece on their peripheral iv disconnected at the end where it connects to the catheter.Iv was no longer functioning.It was new during the night shift.It then took 3 hours to get a new peripheral intravenous (piv) tubing set placed.Patient was very hard to get an iv on.3 days prior to this event, i had the same thing happen where i found the t-piece disconnected from the catheter.When i reconnected it, it seemed to not want to tighten and kept spinning.This product is a substitute from our normal t-piece connectors for pivs.

• 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: 16643531
• MDR Text Key: 312332485
• Report Number: 16643531
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/08/2023

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 Model Number: 7N8310
• Device Catalogue Number: 7N8310
• Device Lot Number: (10)UR22K04116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Sex: Female