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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, HEMODI
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ARROW INTERNATIONAL INC. ARROW CANNON II PLUS REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODI Back to Search Results
Catalog Number CAR-02800
Device Problem Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports a leak in the hub of the device.The hub started to aspirate air during dialysis.The device was replaced.
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports a leak in the hub of the device.The hub started to aspirate air during dialysis.The device was replaced.
 
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Brand Name
ARROW CANNON II PLUS REPLACEMENT HUB SET
Type of Device
KIT, REPAIR, CATHETER, HEMODI
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8362620
MDR Text Key136894767
Report Number1036844-2019-00129
Device Sequence Number1
Product Code NFK
Combination Product (y/n)N
PMA/PMN Number
K020430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCAR-02800
Was Device Available for Evaluation? No
Date Manufacturer Received03/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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