MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CANNON II PLUS REPLACEMENT HUB SET; CATHETER HEMODIALYSIS NON IMPL

Catalog Number	CAR-02400
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on (b)(6) 2022, cracks were found in the joint when tightening, during used on the patient.No danger to the patient.
Additional Manufacturer Narrative
(b)(4).The customer report of a cracked luer hub was confirmed by complaint investigation of the returned sample.The customer returned one connector assembly for analysis.Visual analysis revealed a crack on the arterial luer hub, adjacent to and on the threads.The crack on the luer hub was at the location of the mold seam.Multiple scratches were also observed.Microscopic examination confirmed the damage and revealed that the crack is consistent with repeated over tightening on the luer hubs.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 arterial and venous lines were flushed with a lab inventory syringe, and the arterial line flushed as intended.A small leak was observed at the location of the crack in the arterial luer hub.No leaks were observed when flushing the venous extension line.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." a device history record review was performed, and no relevant findings were identified.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 or Problem Description
It was reported that: "on (b)(6) 2022, cracks were found in the joint when tightening, during used on the patient.No danger to the patient.

• Brand Name: CANNON II PLUS REPLACEMENT HUB SET
• Common Device Name: CATHETER HEMODIALYSIS NON IMPL
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18933562
• Report Number: 9680794-2024-00252
• Device Sequence Number: 21193707
• Product Code: MPB
• UDI-Device Identifier: 00801902096111
• UDI-Public: 00801902096111
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: CAR-02400
• Device Lot Number: 13F21L0229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown