ARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB CDC-45854-XP1A

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 2020-03-30 for ARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB CDC-45854-XP1A manufactured by Arrow International Inc..

Event Text Entries

[185786978] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[185786979] The customer reports that the dilator tip was shredded after using. The reported defect was detected after 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 Number1036844-2020-00124
MDR Report Key9899070
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-16
Date of Event2020-03-13
Date Mfgr Received2020-03-16
Device Manufacturer Date2019-11-27
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 INC.
Manufacturer Street312 COMMERCE PLACE
Manufacturer CityASHEBORO NC 27203
Manufacturer CountryUS
Manufacturer Postal Code27203
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB
Generic NameCATHETER,INTRAVASCULAR,THERAP
Product CodeFOZ
Date Received2020-03-30
Catalog NumberCDC-45854-XP1A
Lot Number23F19K0130
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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