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

Catalog Number CAR-02400

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the catheter juncture was found cracked and leaking which could not work during the dressing change by the nurse.A second device used with same outcome (documented in mdr #1036844-2018-00148).

Event Description

The customer reports the catheter juncture was found cracked and leaking which could not work during the dressing change by the nurse.A second device used with same outcome (documented in mdr #1036844-2018-00148).

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, HEMODI
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7526791
• MDR Text Key: 108729342
• Report Number: 1036844-2018-00147
• Device Sequence Number: 1
• Product Code: NFK
• Combination Product (y/n): N
• PMA/PMN Number: K020430
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: CAR-02400
• Device Lot Number: 23F16J0471
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1