NDEHP PLUMSET 2CLAVES-SL 1468728 146870489

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 2020-03-30 for NDEHP PLUMSET 2CLAVES-SL 1468728 146870489 manufactured by Icu Medical Costa Rica Ltd..

Event Text Entries

[186804918] Sample is not available for evaluation. Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.
Patient Sequence No: 1, Text Type: N, H10


[186804919] The customer reported a plum set that leaked an hour into chemo drug injection as well as during a flush of normal saline. There was patient involvement, but no harm reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615050-2020-00054
MDR Report Key9898346
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-08
Date of Event2020-02-08
Date Mfgr Received2020-03-08
Device Manufacturer Date2019-07-01
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
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 NameNDEHP PLUMSET 2CLAVES-SL
Generic NameSET, ADMINISTRATION, INTRAVASCULAR
Product CodeFPA
Date Received2020-03-30
Model Number1468728
Catalog Number146870489
Lot Number4113888
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerICU MEDICAL COSTA RICA LTD.
Manufacturer AddressZONA FRANCA GLOBAL LA AURORA HEREDIA CS


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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