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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD CLEO INFUSION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 24" BUCKLE AY 10-10/BX
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Erythema (1840)
Event Date 07/15/2020
Event Type  Injury  
Event Description
Information was received that during use of this smiths medical cadd cleo infusion sets, minimal erythema at infusion site was noticed. No additional adverse effects reported.
 
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Brand NameCADD CLEO INFUSION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis, mn
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, mn 
MDR Report Key10401401
MDR Text Key202711639
Report Number3012307300-2020-06876
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 08/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24" BUCKLE AY 10-10/BX
Device Catalogue Number21-7220-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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