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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SMARTSITE VIALSHIELD; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION SMARTSITE VIALSHIELD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MV0520
Device Problem Device Damaged by Another Device (2915)
Patient Problem Chemical Exposure (2570)
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer declined to return the product for failure investigation.The root cause of this failure was not identified.
 
Event Description
It was reported that the vialshield spike cores stopper pieces of brand wg critical care paclitaxel into the drug vial while preparing in their pharmacy 50% of the time.There was no patient involvement.
 
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Brand Name
SMARTSITE VIALSHIELD
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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8746067
MDR Text Key149649761
Report Number9616066-2019-01761
Device Sequence Number1
Product Code LHI
UDI-Device Identifier10885403228117
UDI-Public10885403228117
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132863
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMV0520
Device Catalogue NumberMV0520
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/28/2019
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
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