MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM; CATHETER PERCUTENEOUS

Model Number	IPN919963
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(6).
Event or Problem Description
It was reported that: 2 different operators tried to pass the swg through the introducer needle but there was resistance.The guide unravelled and it was impossible to pass the guide into the vessel.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer provided photos for analysis, but the complaint of a damaged guide wire could not be confirmed through the images.The instructions for use (ifu) provided with this kit warns the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." 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.
Event or Problem Description
It was reported that: 2 different operators tried to pass the swg through the introducer needle but there was resistance.The guide unravelled and it was impossible to pass the guide into the vessel.Associated complaints: 3006425876-2023-01207.3006425876-2023-01206.3006425876-2023-01205.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # **udi related data quality updates only**.
Event or Problem Description
It was reported that: 2 different operators tried to pass the swg through the introducer needle but there was resistance.The guide unravelled and it was impossible to pass the guide into the vessel.Associated complaints: 3006425876-2023-01207, 3006425876-2023-01206, 3006425876-2023-01205.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM
• Common Device Name: CATHETER PERCUTENEOUS
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18289927
• Report Number: 3006425876-2023-01205
• Device Sequence Number: 6264559
• Product Code: DQY
• UDI-Device Identifier: 10801902096583
• UDI-Public: (01)10801902096583(11)230223(17)250113(10)71F23F0936(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2025
• Device Model Number: IPN919963
• Device Catalogue Number: CS-26122-F
• Device Lot Number: 71F23F0936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 03/22/2024; Not provided
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 03/25/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown