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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
Catalog Number 21-7220-242
Device Problems Bent (1059); Device Operates Differently Than Expected (2913)
Patient Problem Hyperglycemia (1905)
Event Date 05/02/2018
Event Type  Injury  
Event Description
Information was received indicating that this subcutaneous infusion system was not working as expected and that the cannula may have bent shortly after insertion. It was noted that the patient's blood glucose level was 400mg/dl at the time of the event. It was unknown if intervention was taken. No additional adverse patient effects were reported.
 
Manufacturer Narrative
Additional information was received indicating the patient was able to change out their supplies (cartridge, infusion set, and site) and their blood sugars went down. No adverse patient 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 HEALTHCARE MANUFACTURING S.A. DE C.V.
a d no.4
parque industrial internaciona
tijuana, bc
MX
Manufacturer Contact
dave halverson
6000 nathan lane north
bc, MN 55442
7633833310
MDR Report Key7622064
MDR Text Key111765976
Report Number3012307300-2017-02188
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,distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7220-242
Device Lot Number77X083
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/20/2018 Patient Sequence Number: 1
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