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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATION ALARIS SECONDARY ADMIT SET WITH TEXIUM
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CAREFUSION CORPORATION ALARIS SECONDARY ADMIT SET WITH TEXIUM Back to Search Results
Model Number 10013364T
Device Problems Leak/Splash (1354); Chemical Spillage (2894)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2014
Event Type  malfunction  
Event Description
Customer reported chemo leaked from the secondary set where the tubing is connected to the male luer.There was no patient or staff harm and no medical intervention.The customer stated that no further patient/event info is available.
 
Manufacturer Narrative
Manufacturer's report date: (b)(4) 2014.Internal file no: (b)(4).This report was filed by the manufacturer.Unable to determine the cause of the customer's reported leak because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.
 
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Brand Name
ALARIS SECONDARY ADMIT SET WITH TEXIUM
Manufacturer (Section D)
CAREFUSION CORPORATION
san diego CA
Manufacturer Contact
barbara ferris
10020 pacific mesa blvd.
san diego, CA 92121
8586171163
MDR Report Key3695681
MDR Text Key21528538
Report Number9616066-2014-00085
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K931550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/01/2016
Device Model Number10013364T
Device Catalogue Number10013364T
Device Lot Number13035632
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MANUFACTURER/MODEL/LOT UNKNOWN; ADMINISTRATION INFUSION SET:
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