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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CLEO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7230-24
Device Problem Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2020
Event Type  malfunction  
Event Description
It was reported that the cadd cleo infusion device caused cellulitis at the injection site. The reporter did not indicate that any treatment/medical intervention was provided/taken to address the incident. The reporter did indicate however that the incident was resolved. Additional information has been requested, but has not yet been received. Should additional relevant details become available, a supplemental report will be submitted.
 
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Brand NameCLEO
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
NULL
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11692518
MDR Text Key246268872
Report Number3012307300-2021-03292
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 user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2021
Is this an Adverse Event Report? No
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/23/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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