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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXPLUS CLEAR NEEDLE-FREE CONNECTOR(S) EXTENSION SET; SET, EXTENSION, INTRAVASCULAR
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CAREFUSION MAXPLUS CLEAR NEEDLE-FREE CONNECTOR(S) EXTENSION SET; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number MPX9102-C
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/18/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.No investigation was performed.
 
Event or Problem Description
It was reported that the maxplus extension set leaked in the er.There was no harm.
 
Additional Manufacturer Narrative
Supplemental created to revise e3 to nurse and revise e2 to yes/healthcare professional.
 
Event or Problem Description
It was reported that the maxplus extension set leaked in the emergency room after connecting it to the iv catheter.It was further confirmed during follow-up, that there was no patient harm as a result of this event.
 
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Brand Name
MAXPLUS CLEAR NEEDLE-FREE CONNECTOR(S) EXTENSION SET
Common Device Name
SET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8785948
Report Number9616066-2019-01929
Device Sequence Number1690094
Product Code FPA
UDI-Device Identifier10885403237287
UDI-Public10885403237287
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K051499
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 06/18/2019
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
Operator of Device Health Professional
Device Expiration Date04/27/2023
Device Model NumberMPX9102-C
Device Catalogue NumberMPX9102-C
Device Lot Number18047008
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date07/12/2019
Supplement Report FDA Received Date11/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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