MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO SOLUTION SET, NON-VENTED, 10 DROPS/ML, 109" (2.8 M); SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2C8537

Device Problem Material Puncture/Hole (1504)

Patient Problem No Code Available (3191)

Event Date 04/20/2020

Event Type  malfunction  

Event Description

Drops of moisture were found on iv tubing infusing 0.9 ns.After further investigation, a tiny hole was visualized in the tubing.Once noticed, iv tubing was removed from patient and replaced.Lot number unavailable.Clearlink system continu-flo solution set 2c8537 s.

• Brand Name: CLEARLINK/CONTINU-FLO SOLUTION SET, NON-VENTED, 10 DROPS/ML, 109" (2.8 M)
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 10004542
• MDR Text Key: 189197748
• Report Number: 10004542
• 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: 04/23/2020

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: No Information
• Device Model Number: 2C8537
• Device Catalogue Number: 2C8537
• 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: 04/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1