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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7230-24
Device Problem Insufficient Information (3190)
Patient Problems Abscess (1690); Bacterial Infection (1735); Inflammation (1932)
Event Date 10/06/2020
Event Type  malfunction  
Event Description
Information was received a patient had panniculitis and deep abscess infection with staph aureus while using a smiths medical cadd cleo infusion set.
 
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Brand NameCLEO INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
NULL
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
building ap16-1
minneapolis, MN 55442
MDR Report Key11477978
MDR Text Key239662993
Report Number3012307300-2021-02039
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7230-24
Device Lot Number3900357
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/12/2021 Patient Sequence Number: 1
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