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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATION SMARTSITE EXTENSION SET
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CAREFUSION CORPORATION SMARTSITE EXTENSION SET Back to Search Results
Model Number 20039E
Device Problem Split (2537)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2014
Event Type  malfunction  
Event Description
The customer reported that during a ct scan with contrast, they observed a split in the flexible part of the tubing when the injection was commenced using a high pressure injector at a rate of 2.5ml/second.From the reported info, there are no indications of serious injury to the pt or user as a result of this incident.No add'l info provided.
 
Manufacturer Narrative
(b)(4).Although requested, device has not been rec'd.A f/u report will be submitted with failure investigation results should the set be rec'd for eval.
 
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Brand Name
SMARTSITE EXTENSION SET
Manufacturer (Section D)
CAREFUSION CORPORATION
san diego CA
Manufacturer Contact
stephen bilello
10020 pacific mesa blvd.
san diego, CA 92121
8586176477
MDR Report Key3757264
MDR Text Key4468561
Report Number9616066-2014-00220
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K061285
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Not Applicable
Remedial Action Other
Type of Report Initial
Report Date 03/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2016
Device Model Number20039E
Device Catalogue Number20039E
Device Lot Number13086409
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/05/2014
Initial Date FDA Received03/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2013
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
HIGH PRESSURE INJECTOR: MFR/MODEL/SN UNK
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