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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MINIBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION MINIBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MP9229
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Information (3190)
Date of Event 08/26/2019
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 discarded and not returned for failure investigation.The root cause of this failure was not identified.
 
Event or Problem Description
It was reported that extension sets came apart.The fused end shot across the room while being used in the infusion suites.Nobody was hurt but they were concerned about this happening.
 
Event or Problem Description
It was reported that extension sets came apart.The fused end shot across the room while being used in the infusion suites.Nobody was hurt but they were concerned about this happening.
 
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Brand Name
MINIBORE EXTENSION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9120863
Report Number9616066-2019-02668
Device Sequence Number11276965
Product Code FPA
UDI-Device Identifier10885403237058
UDI-Public10885403237058
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K051499
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 08/28/2019
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 NumberMP9229
Device Catalogue NumberMP9229
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date09/25/2019
Supplement Report FDA Received Date09/26/2019
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
THERAPY DATE (B)(6) 2019.; THERAPY DATE: UNK
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