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U.S. Department of Health and Human Services

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

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CAREFUSION 303, INC. MAXGUARD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/29/2016
Event Type  malfunction  
Event Description
The carefusion maxguard t-connector extension set (minibore) with injection site (luer slip) slipped out of the catheter hub, resulting in the loss of the piv.
 
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Brand NameMAXGUARD
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
3750 torrey view court
san diego CA 92130
MDR Report Key5938731
MDR Text Key54274436
Report Number5938731
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 08/09/2016,08/16/2016
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/09/2016
Event Location Hospital
Date Report to Manufacturer08/09/2016
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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