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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 60-IN MINIBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION 60-IN MINIBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number ME2050
Medical Device Problem Code Break (1069)
Health Effect - Clinical Codes No Patient Involvement (2645); No Information (3190)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: (5) 2000e; c25013e, therapy date: unk.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
 
Event or Problem Description
It was reported that the plastic collar is broken.There was no patient involvement.
 
Additional Manufacturer Narrative
Correction on initial report: d.11, h6/patient code.The customer¿s report that the collar is broken was confirmed.The set sample was inspected for kinks, holes/tears in the tubing or damages to the components visual inspection of the set noted the male luer to be damaged with the expected collar piece broken off from the collar base.No other damages or issues were observed with the rest of the set components.Functional testing was deemed unnecessary due to the observed damage.The root cause was identified as related to design of the specific male luer component.The device history record for model me2050 could not be performed due to no lot numbers being provided for the reported suspect set samples.
 
Event or Problem Description
It was reported that the plastic collar is broken which occurs upon connection or disconnection.
 
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Brand Name
60-IN MINIBORE EXTENSION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9865034
Report Number9616066-2020-01071
Device Sequence Number18963997
Product Code FPA
UDI-Device Identifier10885403236266
UDI-Public10885403236266
Combination Product (Y/N)N
Initial Reporter StateTN
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,Followup
Report Date (Section B) 02/27/2020
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 NumberME2050
Device Catalogue NumberME2050
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2020
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date03/23/2020
Supplement Report FDA Received Date07/14/2020
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
(2)10ML NON-BD SYRINGE:30ML BD SYRINGE, TD UNK; (4)2000E; (2)10ML NON-BD SYRINGE:30ML BD SYRINGE, TD: UNK
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