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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 Sticking (1597)
Patient Problem Hyperglycemia (1905)
Event Date 11/22/2016
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. (b)(4).
 
Event Description
It was reported that a cleo® 90 infusion set adhesive was sticking to the white cap. The patient's blood glucose increased and was reported in the high 300s (mg/dl). No medical intervention was required. No permanent injury was reported. See mfr: 3012307300-2016-00670 and 3012307300-2016-00671.
 
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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 Key6216527
MDR Text Key63686534
Report Number3012307300-2016-00672
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,other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 12/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Expiration Date05/28/2020
Device Catalogue Number21-7220-24
Device Lot Number75X098
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2015
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: 12/30/2016 Patient Sequence Number: 1
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