SMITHS MEDICAL CADD CLEO INFUSION SET 21-7220-24

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-31 for SMITHS MEDICAL CADD CLEO INFUSION SET 21-7220-24 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[185921528] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02580
MDR Report Key9907630
Report SourceUSER FACILITY
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-12-16
Date Mfgr Received2020-03-02
Device Manufacturer Date2018-11-28
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE N
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Manufacturer G1SMITHS HEALTHCARE MANUFACTURING S.A DE C.V
Manufacturer StreetAVE CALIDAD NO. 4 PARQUE INDUSTRIALLNTERNACIONAL
Manufacturer CityTIJUANA, 22425
Manufacturer CountryMX
Manufacturer Postal Code22425
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMITHS MEDICAL CADD CLEO INFUSION SET
Generic NameSET, ADMINISTRATION, INTRAVASCULAR
Product CodeFPA
Date Received2020-03-31
Model Number21-7220-24
Catalog Number21-7220-24
Lot Number3677257
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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