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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION GRAV SET 20DP; SET, EXTENSION, INTRAVASCULAR
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CAREFUSION GRAV SET 20DP; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 11059728
Medical Device Problem Codes Disconnection (1171); Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/13/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
 
Event or Problem Description
It was reported the tubing, a gravity set with stopcocks-manifold was used for a patient being prep for anesthesia.After confirming the stopcocks were secure and the line was fastened, the user noticed that the tubing disconnected from the manifold and leaked.Although requested, no further details were provided by the customer for this event.
 
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Brand Name
GRAV SET 20DP
Common Device Name
SET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8824176
Report Number9616066-2019-02051
Device Sequence Number11472947
Product Code FPA
UDI-Device Identifier10885403234644
UDI-Public10885403234644
Combination Product (Y/N)N
Initial Reporter StateAK
Initial Reporter CountryUS
PMA/510(K) Number
K960280
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/03/2019
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 Model Number11059728
Device Catalogue Number11059728
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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