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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CLEO 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CLEO 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No lot number was provided; therefore, device history record review could not be completed.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.(catalog and udi) are unknown.No product information has been provided to date.
 
Event Description
It was reported that in the last 90 days, the patient has experienced two (2) incidents of toxicity.No medical or surgical intervention was reported.
 
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Brand Name
CLEO 90 INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key16278233
MDR Text Key308578546
Report Number3012307300-2023-00776
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 Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/23/2023
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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