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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
No product has been returned, therefore we are unable to confirm the reported problem. Based on available information, no corrective actions will be taken at this time. Smiths medical regularly analyzes complaint data and trends, and will take further actions accordingly.
 
Event Description
It was reported that the patient experienced the following issues with the cleo® 90 infusion set; adhesion issues, cleos ripping out, and some kinked cannulas. The patient stated that they experienced an elevated blood glucose level of 300 mg/dl. In response to this, the patient changed out their supplies and administered a bolus.
 
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Brand NameCLEO® 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
1265 grey fox road
st. paul MN 55112
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7507682
MDR Text Key108020193
Report Number3012307300-2018-10175
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/11/2018 Patient Sequence Number: 1
Treatment
NOVOLOG
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