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

Catalog Number	CAR-02800
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the extension line leak during use on the patient.They changed a new one.No harm for the patient." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the extension line leak during use on the patient.They changed a new one.No harm for the patient." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The photo displays the connector assembly with significant amount of biological material within the extension lines.No evidence of leaking could be confirmed from the photo.The customer returned one connector assembly (j-71524-001a) for analysis.Minor kinking of the extension lines was observed which is consistent in appearance to clamping of the lines.Based on the investigation, it was determined that the kinking was not correlated with the reported event.No other obvious defects or anomalies were observed.Leak testing was performed per amrq-000075 rev.17 which states, "there shall be no liquid leakage in the form of a falling drop of water at 300-320 kpa (43.5-46.4 psi) for 30 sec when tested per bs en iso-10555-1 annex c." both luer hubs were individually attached to a leak tester.With the distal end of the metal cannulas occluded, the extension lines were pressurized to 300 kpa for 30 seconds.No leaking was observed on any portion of the connector assembly, including the extension lines and metal cannulas.A manual tug test confirmed both the arterial and venous luer hubs were securely attached to their respective extension lines.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user, "examine catheter and extension lines before and after each treatment for any signs of damage.Do not use sharp instruments near extension lines or catheter.Repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure." the complaint of a leaking connector assembly was not able to be confirmed through complaint investigation of the returned sample.The connector assembly passed all relevant visual and functional requirements.A leak test performed in accordance with iso-10555-1 did not reveal any leaks along the connector assembly or extension lines.Based on the customer report and sample received, no problem was identified with the returned device.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW CANNON II PLUS REPLACEMENT HUB SET
• Common Device Name: 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: 20772330
• Report Number: 9680794-2024-01134
• Device Sequence Number: 8088505
• Product Code: NFK
• UDI-Device Identifier: 00801902096128
• UDI-Public: (01)00801902096128(11)240716(17)270630(10)33F24E0785(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: CAR-02800
• Device Lot Number: 33F24E0785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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