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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD CLEO INFUSION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 24" BUCKLE AY 10-10/BX
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Fever (1858); Inflammation (1932); Pain (1994)
Event Date 11/11/2019
Event Type  malfunction  
Manufacturer Narrative
Report source: foreign country: (b)(6).
 
Event Description
Information was received indicating that during use of this smiths medical cadd cleo infusion sets, the patient experienced feeling worse with fever and was admitted to the hospital. It was reported that the patient was diagnosed with cellulite and discharged with antibiotics. Furthermore, the patient complained about pain in the area of insertion, inflammation and erythema, as well as minimal suppuration prior to this event. Additional information received that the cellulites was treated with antibiotics and the outcome of the event was resolved. No additional adverse effects were reported.
 
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Brand NameCADD CLEO INFUSION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, mn 
3833310
MDR Report Key9765504
MDR Text Key181434585
Report Number3012307300-2020-01654
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 distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24" BUCKLE AY 10-10/BX
Device Catalogue Number21-7230-24
Device Lot Number3675103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/27/2020 Patient Sequence Number: 1
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