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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET
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CAREFUSION NON-VENTED BLOOD SET Back to Search Results
Model Number 2477-0000
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, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Although requested, patient demographics not provided.Although lot number 18089540 was provided, was not in the database, not a valid lot number.
 
Event or Problem Description
The customer reported a general complaint with no specific details that the tubing leaked onto the patient.Although requested, no further information was received.
 
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Brand Name
NON-VENTED BLOOD SET
Common Device Name
BLOOD SET
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8271967
Report Number9616066-2019-00197
Device Sequence Number1234210
Product Code FPA
UDI-Device Identifier07613203011310
UDI-Public7613203011310
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K894842
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/20/2018
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 Number2477-0000
Device Catalogue Number2477-0000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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