MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. BAXTER 2 LITER TPN BAG; SET I.V FLUID TRANSFER

Catalog Number H938740

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2018

Event Type  malfunction  

Event Description

A 2 liter tpn bag from baxter has a leak at the central valve.This problem was discovered before the bag left the facility after tpn was mixed.

• Brand Name: BAXTER 2 LITER TPN BAG
• Type of Device: SET I.V FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 7984505
• MDR Text Key: 124701368
• Report Number: MW5080703
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: H938740
• Device Lot Number: 60119787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1