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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
Device Problems Bent (1059); Kinked (1339)
Patient Problem Hyperglycemia (1905)
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
It was reported that the cannula of a cleo® 90 infusion set bent/kinked after insertion and during use. It was noted that the patient did not notice any damage when the device packaging was first opened. The patient's blood glucose levels were up to 380mg/dl at the time of the event. The patient did not test for ketones. To address the high blood glucose levels, the patient administered a correction bolus through their pump, a manual injection, and successfully performed a site change. No permanent injury was reported. See mfr: 3012307300-2017-01262 through 3012307300-2017-01312.
 
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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
jennifer meng
6000 nathan lane north
minneapolis, MN 55442
7633833078
MDR Report Key6643245
MDR Text Key77636062
Report Number3012307300-2017-01275
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
Report Date 06/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2017
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 Initial

Patient Treatment Data
Date Received: 06/15/2017 Patient Sequence Number: 1
Treatment
NOVOLOG INSULIN
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