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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE 30ML SYRINGE, PISTON

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CAREFUSION TEXIUM NEEDLE-FREE SYRINGE 30ML SYRINGE, PISTON Back to Search Results
Model Number MY8030
Device Problems Fluid Leak (1250); Particulates (1451)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
It was reported that a texium syringe had major employee safety and patient safety concerns. First noticed 7 years ago when the texium product was implemented. This residue found occurs at least 90% of the time when using texium to compound hazardous drugs and biologics. All of these documented issues happened in the pharmacy and did not reach the patient. To resolve the issue, visible residue was deactivated and removed from the outside of the closed system drug-transfer device. The pharmacist remade the drug that was visibly cored and used filter set to verify that nothing reached the patient.
 
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Brand NameTEXIUM NEEDLE-FREE SYRINGE 30ML
Type of DeviceSYRINGE, PISTON
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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9291568
MDR Text Key181743127
Report Number9616066-2019-03116
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMY8030
Device Catalogue NumberMY8030
Device Lot Number91901605
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2019
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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