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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 004197
Device Problem Sticking (1597)
Patient Problem Hyperglycemia (1905)
Event Date 07/21/2016
Event Type  Injury  
Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation. 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
Customer reported cleo 90 infusion sets fell off due to being stuck to the cap before opening the site. This report represents the first of two infusion sets affected by this issue on the given date of event. Blood glucose was adversely affected and reported to be at 400mg/dl. The site was changed and a bolus was delivered to address the high blood glucose. No injury was reported. Please note the following medwatch forms are related: 2183502-2016-01796, 2183502-2016-01797, 2183502-2016-01804, 2183502-2016-01805, 2183502-2016-01806, 2183502-2016-01807, 2183502-2016-01808, and 2183502-2016-01809.
 
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Brand NameCLEO® 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
lisa perz
1265 grey fox rd.
st. paul, MN 51122
7633833074
MDR Report Key5897265
MDR Text Key52831851
Report Number2183502-2016-01797
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
1 Patient was Involved in the Event
Date FDA Received08/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number004197
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 Received07/27/2016
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

Patient Treatment Data
Date Received: 08/23/2016 Patient Sequence Number: 1
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