MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC 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 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2024, the luer hub was found a crack during used on the patient.Associated 9680794-2024-00165, 9680794-2024-00168 and 9680794-2024-00166.

Manufacturer Narrative

Qn#(b)(4).The customer returned one hemodialysis connector assembly for analysis.Signs of use were observed on and within the returned sample.Visual analysis revealed the red arterial luer hub on the connector assembly was a non-arrow component.It appeared that the arrow arterial luer hub had been removed and replaced by the non-arrow component.No other defects or anomalies were observed on the non-arrow luer hub.The customer was contacted for additional information.Based on their response, it is unknown why and when the non-arrow hub was used with the connector assembly.No defects or anomalies were observed on the blue venous luer hub or the rest of the connector assembly.The blue venous luer hub of the connector assembly was functionally tested per the instructions for use (ifu) provided with this kit, which instructs the user, "flush catheter thoroughly with sterile normal saline for injection to remove residual blood, post-treatment and before instilling heparin".The venous line was flushed with a lab inventory syringe, and the line flushed as intended.No leaks were observed when flushing the non-arrow arterial extension line.A manual tug test confirmed the venous luer hub was secure to the extension line.A device history record review was performed, and no relevant findings were identified.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 bill of materials (bom) of the reported finished good was reviewed as a part of this complaint investigation.The kit does not include extension lines separated from the connector assembly.The customer report of a cracked luer hub was not confirmed by complaint investigation of the returned sample.The arterial luer hub on the returned sample had been removed and replaced by a non-arrow luer hub.No damage was observed on either the non-arrow luer hub nor the blue venous luer hub.Additional information from the customer could not determine when and why the non-arrow luer hub was attached to the connector assembly.Based on the customer report and the condition of the sample received, the root cause cannot be determined.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that (b)(6) 2024, the luer hub was found a crack during used on the patient.Associated 9680794-2024-00165, 9680794-2024-00168 and 9680794-2024-00166.

• Brand Name: 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: 18766726
• MDR Text Key: 336988209
• Report Number: 9680794-2024-00165
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CAR-02400
• Device Lot Number: 13F21L0229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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: NOT REPORTED; NOT REPORTED