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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 21-7220-24
Device Problem Partial Blockage (1065)
Patient Problem Hyperglycemia (1905)
Event Date 08/29/2017
Event Type  Injury  
Event Description
It was reported that when the patient was attempting to fill the tubing of a cleo® 90 infusion set, drops of insulin were not visible at the end of the tubing. The patient did not observe any damage to the device packaging when first opened. The patient's blood glucose levels were 289 mg/dl at the time of the event. To address the high blood glucose levels, the patient administered manual injections. The patient did not test for ketones. The patient was able to connect a new set of tubing and filled the tubing until drops of insulin were present. No permanent injury was 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 MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, 22425
MX 22425
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key6855308
MDR Text Key85648446
Report Number3012307300-2017-02032
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586028335
UDI-Public10610586028335
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
Report Date 09/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/27/2022
Device Catalogue Number21-7220-24
Device Lot Number77X026
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/11/2017 Patient Sequence Number: 1
Treatment
NOVOLOG INSULIN
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