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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component (1104); Device Operational Issue (2914)
Patient Problem Hyperglycemia (1905)
Event Date 01/17/2016
Event Type  Injury  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
Distributor reported on behalf of home care patient that during use of device for infusion of insulin the plastic cannula detached from the set and remained under the adhesive. While under the adhesive, the platic cannula would frequently move which resulted in the adhesive becoming detached from the customer's leg (where she wears device). The home care user reported that their blood glucose levels rose due to the interruption in insulin therapy. The home care user reported that they replaced the infusion set and delivered a correction bolus to resolve their high blood glucose. No further adverse effects to user reported.
 
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Brand NameCLEO® 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
SMITHS MEDICAL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
michele seliga
1265 grey fox road
st. paul, MN 55112
7633833052
MDR Report Key5503037
MDR Text Key40388477
Report Number2183502-2016-00502
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 05/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2020
Device Model NumberN/A
Device Catalogue Number21-7230-24
Device Lot Number75X120
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 Received02/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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