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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 2C8537
Device Problem Break (1069)
Patient Problem Underdose (2542)
Event Date 01/09/2020
Event Type  malfunction  
Event Description
Patient had tko fluids running through cvc in her iv. The registered nurse changed the microclave caps and the male end of the iv tubing broke off into the microclave cap unnoticed. The registered nurse connected the iv tubing back to the new microclave cap and started iv doxycycline through the iv. Around 30 minutes later, the registered nurse noticed the patient's gown was wet around the shoulder and found that although the tubing and the microclave cap were screwed together, the medication was dripping onto the patient instead of into the iv due to broken iv tubing.
 
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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 Key9726782
MDR Text Key179945923
Report Number9726782
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 Other Health Care Professional
Type of Report Initial
Report Date 01/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2C8537
Device Catalogue Number2C8537
Device Lot NumberMIJC370
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2020
Event Location Hospital
Date Report to Manufacturer02/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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