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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. MICROCLAVE SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL, INC. MICROCLAVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number B3300
Device Problems Backflow (1064); Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2019
Event Type  malfunction  
Event Description
Rn had just disconnected iv tubing from the patient's internal jugular (ij) catheter. The blood was backflowing out of the ij catheter through the microclave cap onto the bed. The cap appeared as if the inner part had stayed compressed after the line was disconnected. The cap was removed and observed that it had remained compressed as suspected.
 
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Brand NameMICROCLAVE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL, INC.
4455 atherton dr.
salt lake city UT 84123
MDR Report Key8784595
MDR Text Key150849751
Report Number8784595
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 Risk Manager
Type of Report Initial
Report Date 07/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB3300
Device Catalogue NumberB3300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/03/2019
Event Location No Information
Date Report to Manufacturer07/12/2019
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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