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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
Model Number CLEO 90
Device Problem Fail-Safe Problem (2936)
Patient Problem Needle Stick/Puncture (2462)
Event Date 11/18/2016
Event Type  malfunction  
Event Description
It was reported that a cleo® 90 infusion set was being used for training purposes when the user was pricked in the right finger. It was noted that the user took the inserter in his/her hand but the needle removed from the disposable portion when the event occurred. No other injury reported.
 
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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 MEDICAL ASD INC
1265 grey fox road
st paul MN 55112
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key7511193
MDR Text Key108161131
Report Number3012307300-2018-10238
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 05/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLEO 90
Device Catalogue Number21-7230-24
Device Lot Number76X080
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/28/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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