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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,ADMINISTRATION,INTRAVASCULAR
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CAREFUSION EXTENSION SET; SET,ADMINISTRATION,INTRAVASCULAR Back to Search Results
Model Number MP9251-C
Medical Device Problem Code Crack (1135)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Information (3190)
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
It was reported that when the user disconnected the maxplus extension set from the iv site, the clear connection cracked off from the set.Although requested, no further details were provided by the customer for this event.
 
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Brand Name
EXTENSION SET
Common Device Name
SET,ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8801300
Report Number9616066-2019-01964
Device Sequence Number18912063
Product Code FPA
UDI-Device Identifier10885403237188
UDI-Public10885403237188
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K051499
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/24/2019
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 NumberMP9251-C
Device Catalogue NumberMP9251-C
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
PRI TUBING, TD: UNK
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