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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2C6255
Device Problems Kinked (1339); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2018
Event Type  malfunction  
Event Description
The tubing kinks over itself right out of the package, tubing is very pliable tubing. Per site reporter: spoke to the manufacturer surveillance department. They are sending me a return kit.
 
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Brand NameCLEARLINK/CONTINU-FLO
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
round lake IL 60073
MDR Report Key7312764
MDR Text Key101511157
Report Number7312764
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2C6255
Device Catalogue Number2C6255 S
Device Lot NumberR17K22011
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/26/2018
Event Location Hospital
Date Report to Manufacturer02/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/05/2018 Patient Sequence Number: 1
Treatment
NO; NO OTHER THERAPIES
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