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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CLEO SUBCUTANEOUS INFUSION SYSTEMS

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ST PAUL CLEO SUBCUTANEOUS INFUSION SYSTEMS Back to Search Results
Catalog Number 21-7230-24
Device Problem Failure to Clean Adequately (4048)
Patient Problems Unspecified Infection (1930); Rash (2033)
Event Date 02/09/2020
Event Type  Injury  
Event Description
Information received a smiths medical cadd cleo infusion set caused rash on abdomen and infection. Unknown type of infection, if superficial or septic requiring intervention to preclude serious injury. Additional information was sought but no further information to exclude serious injury.
 
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Brand NameCLEO
Type of DeviceSUBCUTANEOUS INFUSION SYSTEMS
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 Key10094366
MDR Text Key192356232
Report Number3012307300-2020-05145
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7230-24
Device Lot Number3675103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/27/2020 Patient Sequence Number: 1
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