MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP EXACTAMIX 1000 ML EVA CONTAINER; SET I.V. FLUID TRANSFER

Catalog Number H938739

Device Problem Misassembled (1398)

Patient Problem No Information (3190)

Event Date 07/17/2018

Event Type  malfunction  

Event Description

The right port is assembled incorrectly on bag.The entire port is exposed and no connected to the exactamix 1000 ml eva container - seems to be manufacturing error.

• Brand Name: EXACTAMIX 1000 ML EVA CONTAINER
• Type of Device: SET I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP
• MDR Report Key: 7743111
• MDR Text Key: 116218781
• Report Number: MW5078827
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: H938739
• Device Lot Number: 60126009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1