MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO SOLUTION, 3 LUER, RETRACT COLLAR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2C8537

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Event Description

Luer lock connection male end of iv tubing broke into pieces while disconnecting from peripheral iv.Propofol, fentanyl and lasix drips were actively running into this line.No harm was caused to patient but new iv tubing had to be primed quickly to prevent harm.No lot or expiration date, reporter has no additional information.

• Brand Name: CLEARLINK/CONTINU-FLO SOLUTION, 3 LUER, RETRACT COLLAR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 14117442
• MDR Text Key: 289338397
• Report Number: 14117442
• 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: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2C8537
• Device Catalogue Number: 2C8537
• 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: 04/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1