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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CLEO 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Contact Dermatitis (4546)
Event Type  malfunction  
Manufacturer Narrative
Other text: this mdr was generated under protocol b10010116, as a result of warning letter (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.D4: catalog number is unknown.D4: udi information is unknown.G5: premarket (510k) number is unknown.
 
Event Description
It was reported that the device was causing dermatitis in the patient.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)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key16873641
MDR Text Key314641030
Report Number3012307300-2023-05114
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2023
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 Received04/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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