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 with the FDA on 2019-09-04 for ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM CS-15122-F manufactured by Arrow International Inc..

MAUDE Entry Details

Report Number1036844-2019-00933
MDR Report Key8959720
Date Received2019-09-04
Date of Report2019-08-20
Date of Event2019-08-20
Date Mfgr Received2019-09-24
Device Manufacturer Date2018-12-17
Date Added to Maude2019-09-04
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 ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1ARROW INTERNATIONAL INC.
Manufacturer Street312 COMMERCE PLACE
Manufacturer CityASHEBORO NC 27203
Manufacturer CountryUS
Manufacturer Postal Code27203
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
Generic NameCATHETER SUBCLAVIAN
Product CodeLFJ
Date Received2019-09-04
Returned To Mfg2019-08-28
Catalog NumberCS-15122-F
Lot Number71F18M1489
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-04

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