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U.S. Department of Health and Human Services

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

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CAREFUSION 303, INC. MAXZERO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ1000-07
Device Problems Difficult to Remove (1528); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2018
Event Type  malfunction  
Event Description
Maxzero cap stuck and unable to remove. Staff needed to use metal "kelly" clamps to remove cap.
 
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Brand NameMAXZERO
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key7493753
MDR Text Key107585545
Report Number7493753
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 Patient
Type of Report Initial
Report Date 05/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Expiration Date11/28/2020
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
Device Lot Number(10)17118625
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/02/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer05/02/2018
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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