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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CLEO INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 21-7221-24
Device Problems Fluid Leak (1250); Deformation Due to Compressive Stress (2889)
Patient Problem Hyperglycemia (1905)
Event Date 09/04/2020
Event Type  malfunction  
Event Description
Information was received that the cadd cleo infusion sets did not deliver the insulin. The cannula of the catheter was reportedly kinked during pricking. Patient experienced very high blood sugar at 566 mg, high proportions of ketones, shortness of breath and other physical complications. Patient was able to reduce their blood sugar without external/medical help because they had an insulin pen they used. Customer has since been using a different lot and reportedly no longer experiences this event.
 
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Brand NameCLEO
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
NULL
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10727784
MDR Text Key212765516
Report Number3012307300-2020-10566
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7221-24
Device Catalogue Number21-7221-24
Device Lot Number3939064
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2020
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: 10/23/2020 Patient Sequence Number: 1
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