CANNON II PLUS REPLACEMENT HUB SET CAR-02400

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 2016-11-07 for CANNON II PLUS REPLACEMENT HUB SET CAR-02400 manufactured by Arrow International Inc..

Event Text Entries

[59335808] (b)(4). This report is for the second in a series of two consecutive product problems with the same patient. The first issue has been reported under mdr # 1036844-2016-00556.
Patient Sequence No: 1, Text Type: N, H10


[59335809] This is the second complaint involving the same patient. It was reported that in nephrology, the user successfully inserted a chronic hemodialysis catheter into the patient's jugular. After one month in use, the nurse found leakage when the patient had hemodialysis treatment. As a result, new extension tube was replaced, however, after several hemodialysis treatments, the extension tube cracked again. Doctor replaced another new extension tube. A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence. The patient involved was a (b)(6) yr/old male, 173cm tall, weighing (b)(6).
Patient Sequence No: 1, Text Type: D, B5


[61514364] (b)(4). Complaint verification testing could not be performed because no sample was returned for analysis. A device history record review was performed and it did not reveal any manufacturing related issues. The probable cause of a leak in the connector assembly could not be determined based upon the information provided and without a sample. No further action will be taken.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1036844-2016-00557
MDR Report Key6081589
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-11-07
Date of Report2016-10-12
Date of Event2016-10-10
Date Mfgr Received2016-12-01
Device Manufacturer Date2014-06-24
Date Added to Maude2016-11-07
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 ContactJAMIE HARTZ
Manufacturer Street2400 BERNVILLE ROAD
Manufacturer CityREADING PA 19605
Manufacturer CountryUS
Manufacturer Postal19605
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 NameCANNON II PLUS REPLACEMENT HUB SET
Generic NameCHRONIC HEMODIALYSIS PRODUCTS
Product CodeNFK
Date Received2016-11-07
Catalog NumberCAR-02400
Lot Number23F14F1348
ID Number00801902031563
Device Expiration Date2017-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-07

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