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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS ADMINISTRATION SET; SET, EXTENSION, INTRAVASCULAR
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CAREFUSION ALARIS ADMINISTRATION SET; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number MX9968
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Information (3190)
Date of Event 08/11/2019
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 device be received for evaluation.
 
Event or Problem Description
It was reported that while the nurse was at the patient's bedside, the tubing became tangled.The nurse was trying to assist patient when tubing pulled apart.There were no leaks and no patient harm.
 
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Brand Name
ALARIS ADMINISTRATION SET
Common Device Name
SET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9163782
Report Number9616066-2019-02827
Device Sequence Number2308137
Product Code FPA
UDI-Device Identifier10885403237805
UDI-Public10885403237805
Combination Product (Y/N)N
Initial Reporter StateGA
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
Report Date (Section B) 08/12/2019
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 Date03/26/2024
Device Model NumberMX9968
Device Catalogue NumberMX9968
Device Lot Number19036670
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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