16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE?, 0.2 MICRON FILTER, CLAVE?, SPIRO CH3381

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 2020-03-30 for 16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE?, 0.2 MICRON FILTER, CLAVE?, SPIRO CH3381 manufactured by Icu Medical De Mexico, S. De R.l. De C.v..

MAUDE Entry Details

Report Number9617594-2020-00094
MDR Report Key9897808
Report SourceUSER FACILITY
Date Received2020-03-30
Date of Report2020-03-12
Date of Event2019-12-01
Date Mfgr Received2020-03-13
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCHRISTOPHER ZANONI
Manufacturer Street600 N. FIELD DR.
Manufacturer CityLAKE FOREST IL 60045
Manufacturer CountryUS
Manufacturer Postal60045
Manufacturer Phone2247062300
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE?, 0.2 MICRON FILTER, CLAVE?, SPIRO
Generic NameSET. ADMINISTRATION, INTRAVASCULAR
Product CodeFPA
Date Received2020-03-30
Catalog NumberCH3381
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
Manufacturer AddressAVENIDA CUARZO NO. 250 ENSENADA, B.CFA. 22790 MX 22790


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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