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

Catalog Number	CU-23122-F
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the dilator tip was found damaged during use on the patient.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#: (b)(4).
Additional Manufacturer Narrative
(b)(4), the customer report of a dilator tip damage was confirmed through investigation of the returned sample.The customer provided two images of the kit components within the tray and dilator; and returned multiple components of a hemodialysis kit, including one dilator, catheter, guide wire assembly, and 18ga introducer needle, for analysis.No definite signs of use were observed.Visual analysis of the dilator tip revealed slight folding of the edges.The appearance of the damage is consistent with undue force applied to the dilator during an attempted insertion.No other obvious defects or anomalies were observed.The overall length of the dilator measured 5 1/2" via calibrated ruler which was within the specification limits of 5 1/4" - 5 3/4" per the dilator product drawing.The outer diameter (od) of the dilator measured 4.00mm via calibrated caliper which was within the specification limits of 3.97mm - 4.06mm per the dilator extrusion graphic.The inner diameter (id) of the dilator at the proximal end measured 0.056" via calibrated pin gauge, or 1.4224mm, which was within the specification limits of 1.40mm - 1.47mm per the dilator extrusion graphic.The id of the dilator at the distal tip could not be 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".The returned guide wire was advanced through the dilator, and little to no resistance was experienced.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." a device history record review was performed and no relevant findings were identified.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.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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17498613
• Report Number: 3006425876-2023-00734
• Device Sequence Number: 12461609
• 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
• Report Date (Section B): 07/14/2023

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 Catalogue Number: CU-23122-F
• Device Lot Number: 71F22E7742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 08/31/2023
• 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
• Patient Sex: Unknown