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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 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 with an unspecified issue was returned by the customer.Visual inspection on the extension set found that the male luer collar was cracked and broken.Closer inspection of the break under a lab microscope observed no stress marks or tool marks.No further testing could be performed due to the broken male luer collar.The root cause was identified as related to design of the specific male luer component.
 
Event or Problem Description
Although an unexpected tubing set with an unspecified issue was returned by the customer, a photo taken by the receiving lab appeared to show a broken luer.This photo observation is unconfirmed and will be verified through failure investigation.No further information was made available to date.
 
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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 Key10371287
Report Number9616066-2020-02439
Device Sequence Number19568672
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 other
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 03/04/2020
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 Manufacturer03/04/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/05/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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