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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 420 mg/dl.The site was changed out and an insulin bolus was administered.No further adverse effects were reported.
 
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Brand Name
CLEO® 90 INFUSION SET
Type of Device
SET, 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 Key7502989
MDR Text Key107869921
Report Number3012307300-2018-01373
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,study,us
Reporter Occupation Other
Type of Report Initial
Report Date 05/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age21 YR
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