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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE; SYRINGE, PISTON
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CAREFUSION TEXIUM NEEDLE-FREE SYRINGE; SYRINGE, PISTON Back to Search Results
Model Number MY8060
Device Problems Break (1069); Fluid/Blood Leak (1250); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2019
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer¿s complaint could not be confirmed because the product was not sequestered and will not be returned for failure investigation.The root cause of this failure was not identified.
 
Event Description
It was reported that the syringe broke at bonded site with texium while inverting drug in the vial.
 
Manufacturer Narrative
Correction to initial report date of event.
 
Event Description
It was reported that a pharmacy employee noticed rituximab (800mg) leaking due syringe broke at bonded site with texium while inverting drug in the vial.The user stated; ¿spill was contained and properly decontaminated/cleaned and disinfected with no harm to the user.The dose was discarded and new product used to draw up 800mg dose to inject into bag.
 
Manufacturer Narrative
The customer¿s complaint that the texuim syringe broke was confirmed.A photo provided by the customer showed that the distal portion of the syringe had broken off at the male luer hub.The texium component was still intact and bonded to the broken off portion.The root cause of this failure was not identified.
 
Event Description
It was reported that a pharmacy employee noticed rituximab (800mg) leaking due syringe broke at bonded site with texium while inverting drug in the vial.The user stated; ¿spill was contained and properly decontaminated/cleaned and disinfected with no harm to the user.The dose was discarded and new product used to draw up 800mg dose to inject into bag.
 
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Brand Name
TEXIUM NEEDLE-FREE SYRINGE
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8692019
MDR Text Key147761311
Report Number9616066-2019-01580
Device Sequence Number1
Product Code FMF
UDI-Device Identifier07613203018852
UDI-Public7613203018852
Combination Product (y/n)N
PMA/PMN Number
K071108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMY8060
Device Catalogue NumberMY8060
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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