MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 31 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15312-VFE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the context was a hemodialysis catheter was inserted with success in the patient.The test of the catheter was ok.Patient had the hemodialysis.Machine stated that the catheter had an issue.When patient came back from hemodialysis, it was observed the catheter was kinked.Patient is fine, no medical intervention necessary, no consequence for the patient." this doctor reported that a similar issue had already happened 2 or 3 other times with this reference.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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 "the context was a hemodialysis catheter was inserted with success in the patient.The test of the catheter was ok.Patient had the hemodialysis.Machine stated that the catheter had an issue.When patient came back from hemodialysis, it was observed the catheter was kinked.Patient is fine, no medical intervention necessary, no consequence for the patient." this doctor reported that a similar issue had already happened 2 or 3 other times with this reference.
Event or Problem Description
It was reported "the context was a hemodialysis catheter was inserted with success in the patient.The test of the catheter was ok.Patient had the hemodialysis.Machine stated that the catheter had an issue.When patient came back from hemodialysis, it was observed the catheter was kinked.Patient is fine, no medical intervention necessary, no consequence for the patient." this doctor reported that a similar issue had already happened 2 or 3 other times with this reference.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one connector assembly from a hemodialysis kit for analysis.Signs of use were observed.Visual analysis of the connector assembly revealed scratches on the luer hubs.Additionally, indentations were observed on the extension lines at the location of the clamps.No other defects or anomalies were observed.Visual analysis of the catheter body could not be performed as it was not returned by the customer.The returned connector assembly was functionally tested per the instructions for use (ifu) provided with this kit.The ifu states "flush hub connection assembly with sterile normal saline for injection and clamp extension lines to contain saline within lumen(s)." a lab inventory syringe filled with water was used to flush each extension line.The connector assembly was flushed successfully, and no abnormalities were observed.A device history record review was performed, and no relevant findings were identified.The 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." the customer report of a catheter body kink could not be confirmed through investigation of the returned sample.The customer returned one connector assembly for analysis, and no obvious defects or anomalies were observed.The returned connector assembly passed all relevant functional testing.A device history record review was performed, and no relevant findings were identified.Without the catheter body returned 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.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 31 CM RETR
• 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: 20894330
• Report Number: 9680794-2024-01219
• Device Sequence Number: 7716092
• Product Code: MSD
• UDI-Device Identifier: 10801902112870
• UDI-Public: (01)10801902112870(11)240212(17)270131(10)33F24A0925(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2024

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 Catalogue Number: CS-15312-VFE
• Device Lot Number: 33F24A0925
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 01/03/2025; 03/14/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/07/2025; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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.; NOT REPORTED.
• Patient Sex: Unknown