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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE, 60 ML SYRINGE, PISTON

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CAREFUSION TEXIUM NEEDLE-FREE SYRINGE, 60 ML SYRINGE, PISTON Back to Search Results
Model Number MY8060
Device Problem Fluid Leak (1250)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 09/19/2016
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
The customer reported a syringe leaked during a patient¿s doxorubicin infusion. The nurse had started the infusion, it started to drip at the port. She disconnected the syringe from the iv port, reconnected it and it still continued to drip. Pharmacy was notified and a new syringe with medication was provided. No patient or clinician harm was reported, the set was not sequestered, and no other event details are available.
 
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Brand NameTEXIUM NEEDLE-FREE SYRINGE, 60 ML
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 Key6284865
MDR Text Key66002142
Report Number9616066-2017-00151
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 health professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 10/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2019
Device Model NumberMY8060
Device Catalogue NumberMY8060
Device Lot NumberD611901
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/27/2017 Patient Sequence Number: 1
Treatment
PRI TUBING
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