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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC.; STOPCOCK, I.V. SET
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BAXTER INTERNATIONAL INC.; STOPCOCK, I.V. SET Back to Search Results
Model Number 2C6218
Device Problem Break (1069)
Patient Problem Missed Dose (2561)
Event Date 12/19/2016
Event Type  malfunction  
Event Description
Patient is in the medical icu on 3 high dose vasopressors.While turning the patient the nurse noted the manifold snapped in half and the patient was not receiving the vasopressors.A new manifold was quickly primed and replaced but the patient is now on high doses of vasopressors.Manufacturer response for baxter three gang large bore stopcock manifold, three gang large bore stopcock manifold (per site reporter): our materials management department is working with the manufacturers.This is a substitute product and finding a manifold is challenging.The product will be in the department's possession and is available if the baxter rep wants to take the device or inspect it.
 
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Brand Name
NA
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
baxter healthcare corporation
one baxter parkway
deerfield IL 60015
MDR Report Key6202027
MDR Text Key63202727
Report Number6202027
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2016
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number2C6218
Device Catalogue Number2C6218
Device Lot NumberDR15L14042
Other Device ID NumberREV 2013/11
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/22/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer12/22/2016
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 Number1
Treatment
THE DEVICE WAS CONNECTED TO A CENTRAL ACCESS IV LI
Patient Age66 YR
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