MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. LARGE BORE STOPCOCK WITH EXTENSION SET; STOPCOCK, I.V. SET

Model Number 2C6251

Device Problem Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2023

Event Type  malfunction  

Event Description

Potential condensation on the "large bore stopcock with extension set" found upon opening sealed kit.Appears to be condensation where the iv tubing meets the 2-way stopcock.Product sequestered.Baxter: lot# (10)dr22d27031 and (10)dr22g13062.Manufacturer response for iv tubing, large bore stopcock with extension set (per site reporter) [redacted date] - retrieved the sample.E-mailed baxter.

• Brand Name: LARGE BORE STOPCOCK WITH EXTENSION SET
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16528751
• MDR Text Key: 311150641
• Report Number: 16528751
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2C6251
• Device Catalogue Number: 2C6251
• Device Lot Number: DR22D27031, DR22G13062
• 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: 02/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1