CHEMOCLAVE? UNIVERSAL VENTED VIAL SPIKE CH-70

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-05 for CHEMOCLAVE? UNIVERSAL VENTED VIAL SPIKE CH-70 manufactured by Icu Medical De Mexico, S. De R.l. De C.v..

MAUDE Entry Details

Report Number9617594-2020-00034
MDR Report Key9670691
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-05
Date of Report2020-01-20
Date of Event2020-01-04
Date Mfgr Received2020-01-20
Device Manufacturer Date2019-10-01
Date Added to Maude2020-02-05
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 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 NameCHEMOCLAVE? UNIVERSAL VENTED VIAL SPIKE
Generic NameCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
Product CodeONB
Date Received2020-02-05
Model NumberCH-70
Catalog NumberCH-70
Lot Number4375468
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-02-05

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