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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS, VERSASAFE SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. ALARIS, VERSASAFE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 10796814
Device Problems Backflow (1064); Break (1069); Disconnection (1171); Device Slipped (1584)
Patient Problem Insufficient Information (4580)
Event Date 02/02/2022
Event Type  malfunction  
Event Description
Rn noticed blood backing up in the tubing and that the new kind of iv tubing we are using broke. The disconnection was not at a site that normally comes apart. It was where a needless hub and the tubing meet. The tubing slipped apart.
 
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Brand NameALARIS, VERSASAFE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key13839250
MDR Text Key287542450
Report Number13839250
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 03/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10796814
Device Catalogue Number10796814
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/01/2022
Event Location Hospital
Date Report to Manufacturer03/21/2022
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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