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U.S. Department of Health and Human Services

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

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CAREFUSION 303, INC. MAXGURAD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Fluid/Blood Leak (1250); Device Slipped (1584)
Patient Problem Fluid Discharge (2686)
Event Date 08/12/2016
Event Type  malfunction  
Event Description
Carefusion maxguard t-connector extension set (minibore) with injection site (luer slip) slipped out of piv catheter hub just enough to cause serosanguinous fluid to leak out when being flushed.
 
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Brand NameMAXGURAD
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
3750 torrey view court
san diego CA 92130
MDR Report Key5938723
MDR Text Key54271472
Report Number5938723
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 08/23/2016,08/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/23/2016
Event Location Hospital
Date Report to Manufacturer08/23/2016
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

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