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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR
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CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number ME2017
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
An unexpected return confirmed a male luer break.Visual inspection as received confirmed the male luer collar to be cracked and broken.Closer inspection under a lab microscope observed no stress marks at the break site of the male luer.No tool marks or scratch marks were observed.No further testing could be performed due to the broken male luer collar.Device history record for model me2017 could not be performed due to no lot number being provided by customer.The root cause was identified as related to design of the specific male luer component.
 
Event or Problem Description
Unexpected return with unspecified failure.No additional information was provide.
 
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Brand Name
ALARIS EXTENSION SET
Common Device Name
SET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key10376208
Report Number9616066-2020-02452
Device Sequence Number16879406
Product Code FPA
UDI-Device Identifier10885403236242
UDI-Public10885403236242
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K051499
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 03/19/2020
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 NumberME2017
Device Catalogue NumberME2017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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