MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15242-SP
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the luer hub/fitting has a crack during use on the patient." the operator changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional 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 and within the device.Visual analysis revealed scratch/stress markings and a crack on the red, arterial luer hub.The appearance of this damage is consistent with overtightening or repeated tightening of the hubs.No defects or anomalies were observed on the blue, venous luer hub.Both luer connections were functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "flush each catheter lumen with sterile normal saline for injection, to establish patency and prime lumen(s) and flush the irrigation tube." a lab inventory syringe filled with water was used to flush each extension line.No leaking was observed from either of the luer hubs.A manual tug test confirmed both luer hub were securely attached to their respective lumens.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "examine catheter and extension lines before and after each treatment for any signs of damage.Repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure." the report of damaged luer hubs was confirmed through complaint investigation of the returned sample.Visual analysis revealed the red, arterial luer hub contained damage consistent with overtightening or repeated tightening of the hubs.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported " on (b)(6) 2024, the doctor found the luer hub/fitting has a crack during use on the patient." the operator changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• 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: 20843283
• Report Number: 9680794-2024-01199
• Device Sequence Number: 20829220
• Product Code: MSD
• UDI-Device Identifier: 00801902096326
• UDI-Public: (01)00801902096326(11)231207(17)261130(10)33F23K0191(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111117
• 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): 11/12/2024

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: CS-15242-SP
• Device Lot Number: 33F23K0191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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
• Patient Sex: Unknown