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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION NEEDLE-FREE VALVE; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION NEEDLE-FREE VALVE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number NFV
Device Problems Crack (1135); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/05/2018
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
 
Event Description
The customer reported that the needle-free connector valve connected to the cvp stopcock cracked upon removal of the flush syringe used during administration of an unknown medication.There was no report of patient harm.
 
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Brand Name
NEEDLE-FREE VALVE
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 Key7902600
MDR Text Key121505921
Report Number9616066-2018-01785
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 Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNFV
Device Catalogue NumberNFV
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
CVP STOPCOCK,FLUSH SYRINGE, THERAPY DATE (B)(6) 2018
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