ARROW RA CATH KIT: 20 GA X 1-3/4" (4.45 CM) ASK-04020-MHS

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 2020-03-23 for ARROW RA CATH KIT: 20 GA X 1-3/4" (4.45 CM) ASK-04020-MHS manufactured by Arrow International Inc..

Event Text Entries

[184498295] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[184498296] The customer reports that the needle separated or "broke off" from the rest of the assembly. The doctor secured the piece of metal protruding from the patient and removed it. The reported defect was detected during use. The patient condition is reported as "fine". There was no patient complication, injury or consequence. Therapy was not delayed/interrupted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680794-2020-00161
MDR Report Key9866323
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-23
Date of Report2020-03-10
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-05-22
Date Added to Maude2020-03-23
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 KIT: 20 GA X 1-3/4" (4.45 CM)
Generic NameWIRE, GUIDE, CATHETER
Product CodeDQX
Date Received2020-03-23
Returned To Mfg2020-03-16
Catalog NumberASK-04020-MHS
Lot Number13F19E0500
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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