MAUDE Adverse Event Report: SMITHS MEDICAL, INC. MEDEX; FILTER, INFUSION LINE

Model Number MX448HFB

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/02/2017

Event Type  malfunction  

Event Description

During report, nurses were checking the lipid infusion and discovered that the lipids were leaking from the connection between the tubing and filter.The tubing was discarded and the packaging was not saved.The nurse manager said that there are 6 different lot numbers in stock on the unit.

• Brand Name: MEDEX
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL, INC.; 6250 shier rings rd.; dublin OH 43016
• MDR Report Key: 6479648
• MDR Text Key: 72345413
• Report Number: 6479648
• 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: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MX448HFB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2017
• 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