MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CANNON II PLUS REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODIALYSIS

Catalog Number CAR-02800

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported that "the replacement hub (car-02800) is properly positioned, but blood is still flowing to the location of the fixation with the catheter (green seal and cap are in place, however)".

Event Description

Customer reported that "the replacement hub (car-02800) is properly positioned, but blood is still flowing to the location of the fixation with the catheter (green seal and cap are in place, however)".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and 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.

• Brand Name: ARROW CANNON II PLUS REPLACEMENT HUB SET
• Type of Device: KIT, REPAIR, CATHETER, HEMODIALYSIS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8790185
• MDR Text Key: 151020599
• Report Number: 1036844-2019-00826
• Device Sequence Number: 1
• Product Code: NFK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: CAR-02800
• Device Lot Number: 23F17K0525
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1