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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SMARTSITE® EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION SMARTSITE® EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 30212E
Device Problems Fluid/Blood Leak (1250); Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2017
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
The customer reported that the tubing of an infusion of d5w. 5 ns plus 20meq kcl was noted to be kinked in several places while connected to a patient's central line. While attempting to unkink the tubing, it was noted that the extension tubing was leaking at the connection point to another set. There was no patient harm.
 
Manufacturer Narrative
Correction: omit pri tubing from concomitant medical products on initial report. The customer¿s report of ¿leaked at connection to another set¿ was confirmed. Visual inspection observed a crack in the female luer wall on the opposite end of the injection gate on both sets. No tool marks or signs of over torque were observed. Functional testing was performed; the set leaked from the crack in the female luer. The cause of the leak was a cracked female luer. The root cause of this failure is the result of multiple contributing factors such as material regrind, gate location and the effect of chemical agents on mechanical connections of the luer.
 
Event Description
The customer reported that the during an infusion of d5w and 0. 45% ns plus 20meq kcl into the patient¿s central line, the tubing was found kinked in several places. After straightening out the tubing, a leak was detected at the extension set connection point. The extension tubing was replaced without incident. There was no report of patient harm.
 
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Brand NameSMARTSITE® EXTENSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
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 Key6312882
MDR Text Key66861055
Report Number9616066-2017-00250
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number30212E
Device Catalogue Number30212E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Yes
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: 02/08/2017 Patient Sequence Number: 1
Treatment
PRI TUBING,CENTRAL LINE
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