MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION STOPCOCK; STOPCOCK, I.V. SET

Model Number 2C6204

Device Problems Fluid/Blood Leak (1250); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 07/24/2022

Event Type  malfunction  

Event Description

While drawing labs from patient's white lumen, rn felt that they was drawing in air into the syringe and noticed that blood was pooling inside the neutron cap.Rn was using 2 baxter large bore stopcock (item number 2c6204) with lab draw.The neutron cap was replaced with new one, and the old one was left in the dirty utility room for evaluation with a new stopcock for reference.Rn believes that the stopcock could be the cause for blood to leak into the neutron cap.There was no harm in this event.

• Brand Name: STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15248401
• MDR Text Key: 298145746
• Report Number: 15248401
• Device Sequence Number: 1
• Product Code: FMG
• 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: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2C6204
• Device Catalogue Number: 2C6204
• 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: 08/12/2022
• Date Report to Manufacturer: 08/18/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1825 DA
• Patient Sex: Female