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

Catalog Number CAR-02400

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported the extension line was found leaking during hemodialysis.No patient harm was reported.The patient's condition is r eported as fine.

Manufacturer Narrative

Qn# (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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported the extension line was found leaking during hemodialysis.No patient harm was reported.The patient's condition is r eported as fine.

Manufacturer Narrative

(b)(4).The customer returned one connector assembly from a hemodialysis kit for analysis.Signs of use in the form of biological material were observed on the juncture hub.After failing functional testing, a small crack was observed on the arterial luer hub.Visual analysis revealed that the crack was adjacent to the threads.Microscopic examination confirmed the damage and revealed that the cracks are consistent with damage due to repeated over-tightening on the luer hubs.The returned sample was functionally tested in accordance with the instructions for use (ifu).The ifu provided with this kit instructs the user, "establish and maintain catheter patency.Solution and frequency of flushing a venous access catheter should be established in hospital/institutional policy".Water was observed leaking out of the crack on the arterial luer hub.No leaks were observed on the venous luer hub.A manual tug test confirmed both luer hubs were secure to their respective extension lines.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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.The arterial (red) luer hub was cracked.The appearance of the crack is consistent with over-tightening on the luer.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 extension line was found leaking 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: 15956308
• MDR Text Key: 308148899
• Report Number: 9680794-2022-00778
• 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,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CAR-02400
• Device Lot Number: 13F21J0881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEMODIALYSIS; HEMODIALYSIS; HEMODIALYSIS