MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB; CATHETER HEMODIALYSIS NON IMPL

Catalog Number	CDA-22122-U1A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during placement of a vascath for patient needing dialysis in the msicu, it was detected by the operator that the catheter would not pass over the guidewire.When the wire was removed it was bent and unraveling.They obtained a second kit and it recurred".Associated complaints: 9680794-2026-00068.
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of a damaged guidewire was confirmed by visual inspection of the customer supplied photo.The image shows a used guidewire with evidence of unraveling, however, full complaint verification testing to determine the cause of the damage could not be performed as no sample was returned for analysis.Arrow guidewires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the required standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guidewire kinking.Guidewire breakage may occur if a force greater than the design specification is applied during removal.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, 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: "during placement of a vascath for patient needing dialysis in the msicu, it was detected by the operator that the catheter would not pass over the guidewire.When the wire was removed it was bent and unraveling.They obtained a second kit and it recurred".Associated omplaints: 9680794-2026-00068 and 9680794-2026-00069.

• Brand Name: ARROW HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB
• Common Device Name: CATHETER HEMODIALYSIS NON IMPL
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24065946
• Report Number: 9680794-2026-00069
• Device Sequence Number: 9113639
• Product Code: MPB
• UDI-Device Identifier: 00801902096166
• UDI-Public: (01)00801902096166(11)250616(17)261218(10)33F25D0419(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K993933
• 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): 12/22/2025

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 Catalogue Number: CDA-22122-U1A
• Device Lot Number: 33F25D0419
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2025
• 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