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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO INFUSION SETS

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SMITHS MEDICAL ASD, INC. CLEO INFUSION SETS Back to Search Results
Catalog Number 21-7231-24
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/08/2021
Event Type  Injury  
Event Description
Information received a smiths medical subcutaneous infusion systems|cadd cleo infusion sets reported the catheter's canula stayed inside patient's skin at adhesive removal. No information on how the device was removed\.
 
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Brand NameCLEO
Type of DeviceINFUSION SETS
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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key12140852
MDR Text Key260670765
Report Number3012307300-2021-06984
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7231-24
Device Lot Number3863359
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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