ARROW CANNON II PLUS REPLACEMENT HUB SET CAR-02800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-22 for ARROW CANNON II PLUS REPLACEMENT HUB SET CAR-02800 manufactured by Arrow International Inc..

Event Text Entries

[136897498] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[136897499] The customer reports a leak in the hub of the device. The hub started to aspirate air during dialysis. The device was replaced.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1036844-2019-00128
MDR Report Key8362659
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-02-22
Date of Report2019-02-08
Date of Event2019-02-08
Date Mfgr Received2019-03-27
Date Added to Maude2019-02-22
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 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 CANNON II PLUS REPLACEMENT HUB SET
Generic NameKIT, REPAIR, CATHETER, HEMODI
Product CodeNFK
Date Received2019-02-22
Returned To Mfg2019-03-06
Catalog NumberCAR-02800
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-22

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