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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION TEXIUM CLOSED MALE LUER SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION TEXIUM CLOSED MALE LUER SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 10012241-0500
Device Problem Retraction Problem (1536)
Patient Problem No Information (3190)
Event Date 07/20/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: flush syringe, port; cad nfv. Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the product be received for evaluation.
 
Event Description
It was reported that the user noticed on the texium closed male luer with female cap had a valve issue ( piston slanted) and made it difficult to remove. The rn had to cap the needle port line remove the needless connector and then add the flush syringe to provide a post therapy flush.
 
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Brand NameTEXIUM CLOSED MALE LUER
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8913247
MDR Text Key155107046
Report Number9616066-2019-02375
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K053049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/22/2022
Device Model Number10012241-0500
Device Catalogue Number10012241-0500
Device Lot Number19026458
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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