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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 21-7230
Device Problem Device Operational Issue (2914)
Patient Problem Hyperglycemia (1905)
Event Date 01/28/2016
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
It was reported that during application of the listed device it would not stick. User's blood glucose level increased to 290 mg/dl as a result of this event. No adverse health outcome reported.
 
Manufacturer Narrative
The reported cleo set, insulin, 9mm inserter/ retractor, 24" buckle was returned for investigation. The returned device was received inside a plastic bag without its original packaging. Visual inspection was at a distance of 12" to 24" and normal conditions of illumination and detected the adhesive was stuck to the white cap. The complaint was confirmed.
 
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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 Key5439771
MDR Text Key38282880
Report Number2183502-2016-00211
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,Followup
Report Date 02/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2020
Device Model Number21-7230
Device Catalogue Number21-7230-24
Device Lot Number75X163
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 Received08/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2015
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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