MAUDE Adverse Event Report: BAXTER HEALTHCARE CONTINU-FLO, 2 CLEARLINK, AND 3-PORT MANIFOLD; STOPCOCK, I.V. SET

Catalog Number 2C8931S

Device Problem Disconnection (1171)

Patient Problem No Information (3190)

Event Date 01/20/2014

Event Type  malfunction  

Event Description

Standard iv with the baxter manifold tubing used by anesthesia disconnected at the side port for no apparent reason.

• Brand Name: CONTINU-FLO, 2 CLEARLINK, AND 3-PORT MANIFOLD
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE; one baxter parkway; deerfield IL 60015 462
• MDR Report Key: 3631500
• MDR Text Key: 20857362
• Report Number: 3631500
• Device Sequence Number: 1
• Product Code: FMG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 2C8931S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR