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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
Model Number 004193
Device Problem Device Operational Issue (2914)
Patient Problem Hyperglycemia (1905)
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 end user's behalf that the adhesive of the listed device was sticking to the cap. According to reporter,user's blood glucose level was elevated and a correction bolus was required as a result of this event. No adverse health outcome resulted.
 
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Brand NameCLEO 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.
1265 grey fox road
st. paul MN 55112
Manufacturer (Section G)
SMITHS MEDICAL ASD INC.
1265 grey fox road
st. paul MN 55112
Manufacturer Contact
michele seliga
1265 grey fox road
st. paul, MN 55112
7633833052
MDR Report Key5428516
MDR Text Key37967870
Report Number2183502-2016-00161
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 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 Received02/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number004193
Device Catalogue Number004193
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 Received01/23/2016
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 Unkown

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