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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CLEO 90 SUBCUTANEOUS INFUSION SET; SET, ADMINISTRATION,INTRAVASCULAR
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ST PAUL CLEO 90 SUBCUTANEOUS INFUSION SET; SET, ADMINISTRATION,INTRAVASCULAR Back to Search Results
Catalog Number 21-7221-24
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Local Reaction (2035)
Event Type  malfunction  
Manufacturer Narrative
Other, other text: d4: udi is unknown.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
 
Event Description
It was reported that the patient had induration.No patient injury was reported.
 
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Brand Name
CLEO 90 SUBCUTANEOUS INFUSION SET
Type of Device
SET, ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key17009266
MDR Text Key315996905
Report Number3012307300-2023-05687
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 Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number21-7221-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/24/2023
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
Patient Sequence Number1
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