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

Catalog Number	CS-15192-VFIE
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "doctor found the catheter to be kinked and there was inadequate flow." the device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine.".
Event or Problem Description
It was reported "doctor found the catheter to be kinked and there was inadequate flow." the device was removed and replaced.There was no patient harm or injury.No medical interveniton required.The patient's current 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.
Additional Manufacturer Narrative
(b)(4).The customer returned one vectorflow chronic hemodialysis antegrade kit for analysis.Visual inspection revealed no signs of use in the form of biological matter.The cuff on the catheter was slightly worn, and very minor discoloration was noted along the catheter body.No other defects or anomalies were observed on any other portion of the returned device.The catheter was functionally tested by using a lab inventory syringe to flush water down both luer hubs.Flushing was successful and there was no resistance or signs of blockage.A device history record review was performed and there was one potential finding; however, it was determined the finding was not relevant to the reported event.The ifu provided with the 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 ifu also states, "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".The customer report of catheter kink could not be confirmed through investigation of the returned sample.Visual inspection revealed the cuff on the catheter was slightly worn, and minor discoloration was noted along the catheter body.No other defects or anomalies were observed on any other portion of the returned device.The device passed functional testing by flushing water through each luer hub.A device history record review was performed, and no relevant findings were identified.Based on the customer report and sample received, no problem was found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "doctor found the catheter to be kinked and there was inadequate flow." the device was removed and replaced.There was no patient harm or injury.No medical interveniton required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE
• 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: 20835397
• Report Number: 9680794-2024-01181
• Device Sequence Number: 8628013
• Product Code: MSD
• UDI-Device Identifier: 10801902127195
• UDI-Public: (01)10801902127195(11)230919(17)260831(10)33F23H0611(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2024

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 Expiration Date: 08/31/2026
• Device Catalogue Number: CS-15192-VFIE
• Device Lot Number: 33F23H0611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/20/2024; 11/19/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/02/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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 Age: 55 YR
• Patient Sex: Female