ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM CS-15122-F

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 2019-11-01 for ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM CS-15122-F manufactured by Arrow International Inc..

MAUDE Entry Details

Report Number3006425876-2019-00854
MDR Report Key9266283
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-01
Date of Report2019-10-21
Date of Event2019-10-17
Date Mfgr Received2019-10-21
Device Manufacturer Date2018-12-17
Date Added to Maude2019-11-01
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 ContactMARGIE BURTON, RN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334965
Manufacturer G1ARROW INTERNATIONAL CR, A.S.
Manufacturer StreetJAMSKA 2359/47
Manufacturer CityZDAR NAD SAZAVOU 591 01
Manufacturer CountryEZ
Manufacturer Postal Code591 01
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
Generic NameCATHETER SUBCLAVIAN
Product CodeLFJ
Date Received2019-11-01
Catalog NumberCS-15122-F
Lot Number71F18M1489
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-01

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