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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 21-7230-24
Device Problems Bent (1059); Kinked (1339)
Patient Problem Hyperglycemia (1905)
Event Date 11/12/2016
Event Type  malfunction  
Manufacturer Narrative
Event date: reporter noted that event occurred in "the past two months" from date of report. 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 a cleo® 90 infusion set had a bent and kinked cannula. The patient's blood glucose was reported to be in the 400-500s (mg/dl). The patient reported she had large ketones and a healthcare professional identified the levels as dangerous/life-threatening. A manual injection was administered or a site change was conducted and a pump bolus was administered to address the high blood glucose. No third-party assistance was required to address the incident. The patient had been using infusion sets "for a while" and did not feel lumps under her skin where infusion sets were inserted. No permanent injury was reported. See mfr: 3012307300-2017-00352, 3012307300-2017-00353, 3012307300-2017-00354, 3012307300-2017-00355, 3012307300-2017-00356, and 3012307300-2017-00357.
 
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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, b.c. 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6323795
MDR Text Key67266043
Report Number3012307300-2017-00351
Device Sequence Number1
Product Code FPA
UDI-Device Identifier30610586028391
UDI-Public30610586028391
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 01/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2021
Device Catalogue Number21-7230-24
Device Lot Number76X151
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 Received01/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2016
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: 02/10/2017 Patient Sequence Number: 1
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