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

Model Number 2C6541S

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2015

Event Type  malfunction  

Event Description

Iv was hung and tubing was primed.I noticed a small particle in the tubing.It did not touch the patient.

• Brand Name: CONTINU-FLO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois 120; rlt-10; round lake IL 60073
• MDR Report Key: 5337819
• MDR Text Key: 34759441
• Report Number: 5337819
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2C6541S
• Device Lot Number: R13E17065
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2015
• Device Age: 1 DY
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR