ARROW EXT DWELL CATH DEVICE 20GAX6CM EDC-00620

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 2020-03-26 for ARROW EXT DWELL CATH DEVICE 20GAX6CM EDC-00620 manufactured by Arrow International Inc..

Event Text Entries

[185088814] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[185088815] The customer reports: the catheter had a slit as if kinked external to the skin. When flushing, the saline was coming out of the slit in the catheter.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680794-2020-00167
MDR Report Key9884816
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-03-11
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-26
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 EXT DWELL CATH DEVICE 20GAX6CM
Generic NameCATHETER INTRAVASCULAR THERAPE
Product CodeFOZ
Date Received2020-03-26
Catalog NumberEDC-00620
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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