TRANSPAC? IT W/ SAFESET? RESERVOIR, RED STRIPE TUBING AND NEEDLESS VALVE 011-46103-93

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 2019-10-24 for TRANSPAC? IT W/ SAFESET? RESERVOIR, RED STRIPE TUBING AND NEEDLESS VALVE 011-46103-93 manufactured by Icu Medical De Mexico, S. De R.l. De C.v..

MAUDE Entry Details

Report Number9617594-2019-00361
MDR Report Key9235816
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-24
Date of Report2019-10-02
Date of Event2019-08-23
Date Mfgr Received2019-11-01
Device Manufacturer Date2018-11-01
Date Added to Maude2019-10-24
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 NameTRANSPAC? IT W/ SAFESET? RESERVOIR, RED STRIPE TUBING AND NEEDLESS VALVE
Generic NameTRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Product CodeDRS
Date Received2019-10-24
Returned To Mfg2019-10-21
Catalog Number011-46103-93
Lot Number3816966
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2019-10-24

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