MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM; CATEHTER HEMODIALYSIS NON IMPL

Model Number	IPN030210
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported the dilator tip was found damaged during use on the patient.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned multiple components of a hemodialysis kit , including one dilator, catheter, and guide wire assembly for analysis.Definite signs of use were observed on the returned components.Visual analysis revealed that the dilator tip was frayed.The appearance of the damage is consistent with undue force applied on the dilator.The overall length of the dilator measured 5 1/2" which is within the specification limits of 5 1/4" - 5 3/4" per the dilator product drawing.The outer diameter of the dilator measured 0.1571" which is within the specification limits of 0.156" - 0.160" per the dilator product drawing.The inner diameter of the dilator measured 0.055" which is within the specification limits of 0.051" - 0.061" per the dilator product drawing.The inner diameter of the dilator at the proximal tip could not be accurately measured due to the damage.The dilator was functionally tested per the instructions for use (ifu) provided with this kit which instructs the user, "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin".A lab inventory guide wire was threaded through the dilator , and was able to pass with little to no resistance.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." the customer report of dilator tip damage was confirmed through investigation of the returned sample.The dilator tip appeared frayed and split.Despite this, the dilator passed all relevant dimensional and functional requirements, and a device history record review revealed no obvious defects or anomalies.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 on reports of this nature.
Event or Problem Description
It was reported the dilator tip was found damaged during use on the patient.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(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 or Problem Description
It was reported the dilator tip was found damaged during use on the patient.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM
• Common Device Name: CATEHTER HEMODIALYSIS NON IMPL
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17197790
• Report Number: 3006425876-2023-00601
• Device Sequence Number: 5440787
• Product Code: MPB
• UDI-Device Identifier: 00801902100269
• UDI-Public: 00801902100269
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2023

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: 02/02/2024
• Device Model Number: IPN030210
• Device Catalogue Number: CU-23122-F
• Device Lot Number: 71F22E7742
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 07/17/2023; 07/26/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/18/2023; 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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; NOT REPORTED
• Patient Sex: Unknown