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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CANNON II PLUS REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODIALYSIS
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ARROW INTERNATIONAL INC. ARROW CANNON II PLUS REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODIALYSIS Back to Search Results
Catalog Number CAR-02400
Device Problems Crack (1135); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/19/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The results of the investigation are pending at the time of this report.
 
Event Description
It is reported that the patient's husband indicated that the catheter they used was cracked after insertion when they did dialysis (this event documented in mdr# 1036844-2017-00196).The hospital replaced the catheter, but the catheter was cracked again when the patient did dialysis.
 
Manufacturer Narrative
(b)(4).The sample was not returned for evaluation.A device history record (dhr) review was performed on the catheter's extension lines and no relevant findings were identified.The instructions for use (ifu) warns that repeated over tightening of bloodlines, syringes, and caps will reduce connector life and could lead to potential connector failure.It also states not to use acetone with this catheter and that the catheter, extension lines and connectors should be examined before and after each use.Complaint verification testing could not be performed because no sample was returned for analysis.A dhr 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.
 
Event Description
It is reported that the patient's husband indicated that the catheter they used was cracked after insertion when they did dialysis (this event documented in mdr# 1036844-2017-00196).The hospital replaced the catheter, but the catheter was cracked again when the patient did dialysis.
 
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Brand Name
ARROW CANNON II PLUS REPLACEMENT HUB SET
Type of Device
KIT, REPAIR, CATHETER, HEMODIALYSIS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6549006
MDR Text Key74592270
Report Number1036844-2017-00197
Device Sequence Number1
Product Code NFK
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/31/2017
Device Catalogue NumberCAR-02400
Device Lot Number23F14F1348
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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