MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SET WITH ONE-LINK NEEDLE-FREE IV CO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 7N8399

Device Problems Difficult to Flush (1251); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2015

Event Type  malfunction  

Event Description

One-link was attached to infant's new central line.Rn unable to flush through the line that was less than 24 hrs old.One-link had been replaced more than once over the night.It seemed to be sticking and nothing able to go through it.

• Brand Name: NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SET WITH ONE-LINK NEEDLE-FREE IV CO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois drive route 120; round lake IL 60073
• MDR Report Key: 5392779
• MDR Text Key: 36914798
• Report Number: 5392779
• 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: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 7N8399
• Device Lot Number: 07-36-71-510
• Other Device ID Number: PEOPLESOFT 15259
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/31/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1