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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE, 60 ML SET, EXTENSION, INTRAVASCULAR

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CAREFUSION TEXIUM NEEDLE-FREE SYRINGE, 60 ML SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number MY8060-0006
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/09/2019
Event Type  malfunction  
Manufacturer Narrative
No product returned. Because no product was returned or expected to be returned, no failure investigation could be performed. The root cause of the customer's experience was not identified.
 
Event Description
The reported feedback suggests that the male luer breaks off. Patient harm undefined at present.
 
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Brand NameTEXIUM NEEDLE-FREE SYRINGE, 60 ML
Type of DeviceSET, EXTENSION, 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 Key9156427
MDR Text Key162026168
Report Number9616066-2019-02810
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMY8060-0006
Device Catalogue NumberMY8060-0006
Device Lot Number91905103
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
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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