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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO INFUSION SET INTRAVASCULAR ADMINISTRATION SET

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SMITHS MEDICAL ASD, INC. CLEO INFUSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 21-7230-24
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Fever (1858)
Event Date 10/23/2020
Event Type  Injury  
Event Description
It was reported the device was in use with patient. Patient noted erythema at the infusion site and patient was feverish. The patient was advised to visit emergency department of local hospital for examination.
 
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Brand NameCLEO INFUSION SET
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10916046
MDR Text Key218627460
Report Number3012307300-2020-11896
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 distributor
Reporter Occupation
Type of Report Initial
Report Date 11/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7230-24
Device Lot Number3900360
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 Received10/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/23/2019
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: 11/28/2020 Patient Sequence Number: 1
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