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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORP. SMARTSITE EXTENSION SET
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CAREFUSION CORP. SMARTSITE EXTENSION SET Back to Search Results
Model Number 20029E
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2013
Event Type  malfunction  
Event Description
Product was received by carefusion unexpectedly.A note with the returned product stated: "no harm because i caught it right away.Iv was a uvc.Baby could have gotten air emboli".The tubing was separated from the smartsite y-port.There was no report of pt harm or medical intervention.No further pt/event info is available.
 
Manufacturer Narrative
Mfr's report date on: 01/15/2014.Internal file no: (b)(4).The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
 
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Brand Name
SMARTSITE EXTENSION SET
Manufacturer (Section D)
CAREFUSION CORP.
san diego CA
Manufacturer Contact
michelle bitto
10020 pacific mesa blvd.
san diego, CA 92121
8586173316
MDR Report Key3821524
MDR Text Key4393484
Report Number9616066-2014-00035
Device Sequence Number1
Product Code FPB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K801614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/23/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2014
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 Number20029E
Device Catalogue Number20029E
Device Lot Number13085791
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/23/2013
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/23/2013
Was Device Evaluated by Manufacturer? No
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
UVC LINE, MFR/MODEL/LOT# UNK
Patient Age12 DA
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