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

Catalog Number CAR-02800

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the hub cracked during use.

Manufacturer Narrative

(b)(4).The customer returned one connector assembly and sleeve for evaluation.The catheter body was not returned.The sample contained obvious signs of use in the form of biological material.Visual examination of the returned connector assembly revealed that the arterial (red) extension line luer hub was cracked.This crack is consistent with over-tightening the luer hub.No other defects or anomalies were observed.The connector assembly was leak tested by attaching a 5 ml lab syringe filled with water to each luer hub and depressing the plunger.When the arterial line was tested, water leaked out of the crack in the extension line hub.Testing the venous extension line did not reveal any leaks.The ifu provided with this kit warns the user, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure.The customer report of a cracked luer hub was confirmed by complaint investigation.The arterial extension line contained one small crack.A functional leak test was performed and no other cracks were detected.Based on the time of discovery and the sample received, it was determined that unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports the hub cracked during use.

• 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: 8245033
• MDR Text Key: 132978184
• Report Number: 1036844-2019-00025
• 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: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAR-02800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1