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

Catalog Number CAR-02400

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the venous luer hub was found cracked during hemodialysis.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one hemodialysis connector assembly and product packaging for evaluation.Signs of use in the form of biological material were observed inside both extension lines.Visual inspection of the luer hubs revealed a small crack at the threading of the venous luer hub.The damage appeared consistent with repeated tightening on the luer.The instructions for use (ifu) provided with this kit states, "flush both lumens of catheter with saline and clamp irrigation tube with catheter pinch clamp".The connector assembly was functionally tested by injecting both lumens using a water-filled lab inventory arrow raulerson syringe (ars).No leaking was observed when injecting either extension line.Water did not leak from the damage to the venous luer hub as the cracks likely did not travel completely through the hub.A device history record review was performed, and a potentially relevant finding was identified: for material c-30101-001, a non-conformance was initiated for lot 13p20h0058 in regards to an extension line separated/torn during use.This finding is not relevant to this complaint investigation.The instructions for use (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 of the returned sample.Visual analysis revealed that the venous luer hub was cracked.The appearance of the crack was consistent with over-tightening on the luer hub.A device history record review was performed and one finding was discovered; however, this finding is not relevant to this complaint investigation.Based on the customer report and the condition of the sample received, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported the venous luer hub was found cracked during hemodialysis.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW CANNON II PLUS REPLACEMENT HUB SET
• Type of Device: KIT, REPAIR, CATHETER, HEMODI
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14859338
• MDR Text Key: 295968225
• Report Number: 9680794-2022-00407
• Device Sequence Number: 1
• Product Code: NFK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K020430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: CAR-02400
• Device Lot Number: 13F21E0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HEMODIALYSIS; HEMODIALYSIS