MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SYSTEM - CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2C8541

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 02/06/2020

Event Type  malfunction  

Event Description

2 sets of iv tubing lot# (10)r19k26036 were found to have iv tubing cut.This was noticed when the tubing was opened up.Both samples were kept.(note: the 2nd package had the cut piece pulled outside of the package.).

• Brand Name: CLEARLINK SYSTEM - CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 9828977
• MDR Text Key: 183272055
• Report Number: 9828977
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2C8541
• Device Catalogue Number: 2C8541
• Device Lot Number: R19K26036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1