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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO; INFUSION
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SMITHS MEDICAL ASD, INC. CLEO; INFUSION Back to Search Results
Model Number 9 MM
Device Problems Detachment of Device or Device Component (2907); Separation Problem (4043)
Patient Problems Swelling (2091); Foreign Body In Patient (2687)
Event Date 12/09/2020
Event Type  Injury  
Event Description
Information was received a smiths medial cleo needle remained under patient skin.Reported when cleo site removed it was noted that the catheter remained in patients arm.It was reported the device was not removed and no intervention was taken as patient was at end of life.
 
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Brand Name
CLEO
Type of Device
INFUSION
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 Key11405131
MDR Text Key234457419
Report Number3012307300-2021-01691
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586028397
UDI-Public10610586028397
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number9 MM
Device Catalogue Number21-7230-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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