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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX EVA CONTAINER 3L SET, I.V, FLUID TRANSFER

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BAXTER HEALTHCARE CORPORATION EXACTAMIX EVA CONTAINER 3L SET, I.V, FLUID TRANSFER Back to Search Results
Lot Number 60218463
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Event Description

Bags are leaking from the middle port.

 
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Brand NameEXACTAMIX EVA CONTAINER 3L
Type of DeviceSET, I.V, FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key10606029
MDR Text Key209454109
Report NumberMW5096961
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 09/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/29/2020
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device LOT Number60218463
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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