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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 6-IN STANDARDBORE TRI-FUSE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION 6-IN STANDARDBORE TRI-FUSE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number ME1224
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
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
 
Event or Problem Description
It was reported that the iv fluid was leaking out at junction of the trifuse extension set.The event occurred in the operating room (or) over the past couple of months.There was no patient harm and the event did not cause delay in patient therapy.
 
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Brand Name
6-IN STANDARDBORE TRI-FUSE EXTENSION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9315679
Report Number9616066-2019-03217
Device Sequence Number607288
Product Code FPA
UDI-Device Identifier10885403236112
UDI-Public10885403236112
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K051499
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/18/2019
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 Date09/03/2023
Device Model NumberME1224
Device Catalogue NumberME1224
Device Lot Number18095129
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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