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

Catalog Number	CS-15192-VFE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the catheter tip was found split during use on the patient.They changed a new one." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the catheter tip was found split during use on the patient.They changed a new one." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened hemodialysis kit including the catheter body component for analysis.Signs of use in the form of biological material were observed, and the catheter body was intentionally severed at the indicated cut mark.Visual analysis revealed the distal tip/catheter connector assembly of the catheter body appeared brittle and had two cracks.Manufacturing was contacted as a part of this complaint investigation and they confirmed the observed defect is consistent with a previously opened capa for the fracturing of the catheter connector assembly.This is due to the validated processing temperature exceeding the manufacturer's recommended processing temperature (maximum recommended temperature is 450 f and the currently validated process is rated at 480 f) , resulting in degradation to the resin causing brittleness in the molded component.A device history record review was performed, and there was one potential finding.A non-conformance was initiated for 13c22l0729 and 13c22l0730 in regard to component c-70008-001 (molded comp: catheter connector), after being assembled and converted to part number c-70010-001, was fracturing.The ifu provided with the kit informs the user, "the arrow edge hemodialysis catheter is a long-term catheter with a v tip design.This catheter is first tunneled antegrade to venous insertion site, followed by vessel access and tip placement".The ifu also states, "do not use if package is damaged".The report of damage to the catheter tip was able to be confirmed through complaint investigation of the returned sample.The distal tip/catheter connector assembly of the catheter body appeared brittle and had two cracks.Based on these circumstances, manufacturing caused or contributed to this event.A capa was implemented on 08-dec-2023 to address the issue of the component fracturing.This implementation date occurred after the manufacturing date of the catheter connector assembly involved with this complaint (05-jan-2023).Therefore, this complaint is within scope of the capa.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 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: 20585618
• Report Number: 9680794-2024-01083
• Device Sequence Number: 8555481
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: (01)10801902127171(11)230919(17)260831(10)33F23G0531(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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-VFE
• Device Lot Number: 33F23G0531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/15/2024
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown