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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. INTERLINK/DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER INTERNATIONAL INC. INTERLINK/DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2C7551
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 03/22/2022
Event Type  malfunction  
Event Description
Leaking noted between drip chamber and tubing.
 
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Brand NameINTERLINK/DUO-VENT
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
one baxter parkway
deerfield IL 60015
MDR Report Key14013627
MDR Text Key288599532
Report Number14013627
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number2C7551
Device Catalogue Number2C7551
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/31/2022
Date Report to Manufacturer04/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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