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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL CADD CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. SMITHS MEDICAL CADD CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7220-24
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Irritation (1941)
Event Date 12/16/2019
Event Type  malfunction  
Event Description
Information was received that while a smiths medical cadd cleo infusion set was in use, two abscesses noted on left abdominal wall at infusion site.Unspecified surgical intervention was done as a result.The incident has been reported to be resolved.
 
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Brand Name
SMITHS MEDICAL CADD CLEO INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis, mn
Manufacturer (Section G)
SMITHS HEALTHCARE MANUFACTURING S.A DE C.V
ave calidad no. 4
parque industriallnternacional
tijuana, 22425
MX   22425
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis, mn 
MDR Report Key9907630
MDR Text Key185921528
Report Number3012307300-2020-02580
Device Sequence Number1
Product Code FPA
UDI-Device Identifier30610586028339
UDI-Public30610586028339
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 user facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date07/19/2023
Device Model Number21-7220-24
Device Catalogue Number21-7220-24
Device Lot Number3677257
Was Device Available for Evaluation? No
Date Manufacturer Received03/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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