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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD INC. CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7231
Device Problem Device Operational Issue (2914)
Patient Problem Hyperglycemia (1905)
Event Type  malfunction  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
According to reporter, site did not adhere upon application. Blood glucose level increased as a result of this event. No adverse health outcome reported.
 
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Brand NameCLEO INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.
1265 grey fox road
st. paul MN 55112
Manufacturer (Section G)
SMITHS MEDICAL ASD INC.
1265 grey fox road
st. paul MN 55112
Manufacturer Contact
michele seliga
1265 grey fox road
st. paul, MN 55112
7633833052
MDR Report Key5442756
MDR Text Key38411158
Report Number2183502-2016-00223
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 02/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2020
Device Model Number21-7231
Device Catalogue Number21-7231-24
Device Lot Number75X147
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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