MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER HEMODIALYSIS NON IMPL

Model Number	IPN919690
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Hematoma (1884); Needle Stick/Puncture (2462)
Date of Event	03/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during insertion the guide was impossible to advance, and it got stuck, it was impossible to remove.The device was replaced." additional information received from the customer states "resistance was observed when i tried to lower the guide into the needle, prompting me to move the needle.I thought it was blocked against the wall, so i repositioned my needle, without success.So i wanted to remove the guide to see if there was still blood reflux and check that the needle was still in the vein, but i couldn't remove the guide and had to remove the guide and needle." the device was removed, and a new set was used requiring the patient to be re-punctured three times which resulted in a hematoma.The third insertion was a success.There was no medical intervention required.The patient's current condition is reported as "deceased".The customer reports "patient deceased within the first 48 hours of treatment (death has no link with the incident).".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return; however, the customer provided one photo for analysis.The complaint of guidewire difficult to advance cannot be confirmed by the photo as the photo does not provide visual evidence of the reported defect.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, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." 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 "during insertion the guide was impossible to advance, and it got stuck, it was impossible to remove.The device was replaced." additional information received from the customer states "resistance was observed when i tried to lower the guide into the needle, prompting me to move the needle.I thought it was blocked against the wall, so i repositioned my needle, without success.So i wanted to remove the guide to see if there was still blood reflux and check that the needle was still in the vein, but i couldn't remove the guide and had to remove the guide and needle." the device was removed, and a new set was used requiring the patient to be re-punctured three times which resulted in a hematoma.The third insertion was a success.There was no medical intervention required.The patient's current condition is reported as "deceased".The customer reports "patient deceased within the first 48 hours of treatment (death has no link with the incident).".

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
• Common Device Name: CATHETER 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: 21889725
• Report Number: 3006425876-2025-00383
• Device Sequence Number: 15482690
• Product Code: MPB
• UDI-Device Identifier: 00801902100122
• UDI-Public: (01)00801902100122(11)240909(17)290831(10)71F24J0212(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K991431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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 Model Number: IPN919690
• Device Catalogue Number: CS-12142-F
• Device Lot Number: 71F24J0212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2024
• 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