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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CLEO SUBCUTANEOUS INFUSION

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ST PAUL CLEO SUBCUTANEOUS INFUSION Back to Search Results
Model Number 90
Device Problem Separation Failure (2547)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Event Description
Information received a smiths medical subcutaneous infusion systems|cadd cleo infusion sets left foreign body in patient body. The patients mother reported that there is a cleo 90 cannula that remained in the patient skin on left arm for almost 2 months now, after removing the infusion site. Patient mother doesn't recall the lot number of the cleo 90 and she has discarded the infusion site. Clarification is requested on the removal of device.
 
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Brand NameCLEO
Type of DeviceSUBCUTANEOUS INFUSION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11872745
MDR Text Key252262257
Report Number3012307300-2021-04917
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number90
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 Received04/28/2021
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

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