MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2R8538

Device Problems Crack (1135); Leak/Splash (1354); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2022

Event Type  malfunction  

Event Description

Stubing hub connected to clave cracked.Iv fluids and medication leaking through the crack, leading patient to likely not having received the full dose of mesna.Rn stopped transfusions, changed claves, flushed lines, checked, and tightened connections.Observed site of leaking to be from hub of primary tubing.Defective tubing taken down, replaced with working tubing.

• Brand Name: CLEARLINK/CONTINU-FLO/DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16050526
• MDR Text Key: 306164872
• Report Number: 16050526
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/16/2022

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 Model Number: 2R8538
• Device Catalogue Number: 2R8538
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Race: White