ARROW RA CATH SET: 20 GA X 1-3/4" RA-04020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for ARROW RA CATH SET: 20 GA X 1-3/4" RA-04020 manufactured by Arrow International Inc..

Event Text Entries

[184312590] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[184312591] Physician went to start an arterial line, prior to using on a patient , they did a guide wire check by advancing the wire. A bend in the guide wire was noted during pre-testing the device was not used. Another device was obtained for patient use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680794-2020-00156
MDR Report Key9860769
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-20
Date of Report2020-03-09
Date of Event2020-03-05
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-12-12
Date Added to Maude2020-03-20
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 DE MEXICO S.A. DE C.V.
Manufacturer StreetAVE. WASHINGTON 3701 COLONIA PANAMERICANA, CHIHUAHUA
Manufacturer CityCHIHUAHUA 31200
Manufacturer CountryMX
Manufacturer Postal Code31200
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARROW RA CATH SET: 20 GA X 1-3/4"
Generic NameWIRE GUIDE CATHETER
Product CodeDQX
Date Received2020-03-20
Catalog NumberRA-04020
Lot Number14F19M0050
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 2020-03-20

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