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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO INFUSION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CLEO INFUSION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Inflammation (1932)
Event Type  malfunction  
Event Description
It was reported that the patient experienced inflammation at the infusion site.No medical or surgical intervention was reported.
 
Manufacturer Narrative
No product sample was received; therefore, visual and functional testing could not be performed.If the product is returned, will reopen this complaint for further investigation.No root cause could be determine since the complaint could not be confirmed since no samples or pictures were received for evaluation.No lot number was provided; therefore, device history record review could not be completed.No product information has been received to date.No information has been received to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
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Brand Name
CLEO INFUSION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15434034
MDR Text Key305423711
Report Number3012307300-2022-19356
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 Non-Healthcare Professional
Type of Report Initial
Report Date 09/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2022
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
Was the Report Sent to FDA? No
Date Manufacturer Received04/19/2022
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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