MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. MICRON DOWNSTREAM FILTER; IV ADMINISTRATION SET

Catalog Number 1C8740

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2016

Event Type  malfunction  

Event Description

Noted tpn leakage from tubing/filter connection onto the bed linens; approximately 9cc fluid on blanket.Changed filter and checked patency of uvc.

• Brand Name: MICRON DOWNSTREAM FILTER
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 6208813
• MDR Text Key: 63429314
• Report Number: 6208813
• Device Sequence Number: 1
• Product Code: FPB
• 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: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 1C8740
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1