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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXZERO NEEDLELESS CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION MAXZERO NEEDLELESS CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ1000-07
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
 
Event Description
The customer reported that in diagnostic imaging, the technologist was uncapping the item from the iv, and saline sprayed up their arm.There's no report of patient harm.
 
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Brand Name
MAXZERO NEEDLELESS CONNECTOR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8201834
MDR Text Key131592513
Report Number9616066-2018-02593
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403230196
UDI-Public10885403230196
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K132413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
IV, TD: (B)(6) 2018.
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