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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,EXTENSION,INTRAVASCULAR
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CAREFUSION EXTENSION SET; SET,EXTENSION,INTRAVASCULAR Back to Search Results
Model Number 10016072
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event or Problem Description
The customer reported that the tubing leaked at the connection.No patient harm was reported.After the event, the event reporter believes that there may have been a drop of fluid on the gland after the syringe was disconnected which is expected product behavior, however the product was not saved after the event.Nursing leadership arranged follow up training for staff on product use.
 
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Brand Name
EXTENSION SET
Common Device Name
SET,EXTENSION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7896478
Report Number9616066-2018-01780
Device Sequence Number2508261
Product Code FPA
UDI-Device Identifier10885403234071
UDI-Public10885403234071
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K960280
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/24/2018
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 Model Number10016072
Device Catalogue Number10016072
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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