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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 Bent (1059); Separation Failure (2547)
Patient Problem Hyperglycemia (1905)
Event Date 08/06/2017
Event Type  Injury  
Event Description
Information was received indicating that the adhesive stuck to the cap of a smiths medical cleo® 90 infusion set; causing the site to pull out of the applicator upon opening. The patient attempted to put site back into the applicator but bent the cannula upon insertion. Blood glucose at time of incident was 420mg/dl. The site was changed out and an insulin bolus was administered. No further adverse effects were reported.
 
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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 rd
st. paul, MN 55112
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key7516027
MDR Text Key108317310
Report Number3012307300-2018-01760
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 consumer,distributor
Reporter Occupation
Type of Report Initial
Report Date 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/12/2018
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 Initial

Patient Treatment Data
Date Received: 05/15/2018 Patient Sequence Number: 1
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