ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM CV-15122-FBZ

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2020-02-10 for ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM CV-15122-FBZ manufactured by Arrow International Inc..

Event Text Entries

[178367085] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[178367086] The customer reports that the guide wire is damaged in the kit.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006425876-2020-00139
MDR Report Key9686932
Report SourceDISTRIBUTOR,FOREIGN,OTHER
Date Received2020-02-10
Date of Report2020-01-28
Date of Event2020-01-19
Date Mfgr Received2020-03-02
Device Manufacturer Date2018-10-29
Date Added to Maude2020-02-10
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 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 Received2020-02-10
Catalog NumberCV-15122-FBZ
Lot Number71F18K1896
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.