MAUDE Adverse Event Report: BAXTER BAXTER ONE-LINK; IV TUBING CONNECTOR

Lot Number (10)UR17FO7094

Device Problem Leak/Splash (1354)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/20/2017

Event Type  malfunction  

Event Description

Piv inserted and iv connector tubing placed on hub of needle and screwed on via luer lock.Flushed with normal saline and clamped.Blood back flowing and leaking out of connector tubing at hub distal to luer lock connector but before clamp.New connector placed without further signs of leaking from piv.Date of use: (b)(6) 2017.Diagnosis or reason for use: peripheral intravenous line."is the product compounded: no; is the product over-the-counter: no; event abated after use stopped or dose reduced: yes.".

• Brand Name: BAXTER ONE-LINK
• Type of Device: IV TUBING CONNECTOR
• Manufacturer (Section D): BAXTER; deerfield IL 60015
• MDR Report Key: 6885774
• MDR Text Key: 87231235
• Report Number: MW5072283
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: (10)UR17FO7094
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 106