MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	ES-04301
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "patient indicated for central venous catheter placement, ultrasound-guided procedure, single puncture, venous return obtained, easily deformable guide advanced, bent only upon contact with the patient, guide must be changed, new catheter opened, guide advanced and prior to millimeter cut to advance dilator, the dilator bends at the tip despite proper technique, a second dilator must be used, subsequently advancing the central venous catheter after 2 unnecessary punctures in the procedure.Dilator bends at the tip despite proper technique, a second dilator must be used, subsequently advancing the central venous catheter after two unnecessary punctures in an ultrasound-guided procedure, punctures required due to failures in the arrow brand central venous catheter." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00935 and 9680794-2025-00992.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "patient indicated for central venous catheter placement, ultrasound-guided procedure, single puncture, venous return obtained, easily deformable guide advanced, bent only upon contact with the patient, guide must be changed, new catheter opened, guide advanced and prior to millimeter cut to advance dilator, the dilator bends at the tip despite proper technique, a second dilator must be used, subsequently advancing the central venous catheter after 2 unnecessary punctures in the procedure.Dilator bends at the tip despite proper technique, a second dilator must be used, subsequently advancing the central venous catheter after two unnecessary punctures in an ultrasound-guided procedure, punctures required due to failures in the arrow brand central venous catheter." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00935 and 9680794-2025-00992.
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.

• Brand Name: ARROW CVC SET: 5 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 23582157
• Report Number: 9680794-2025-00935
• Device Sequence Number: 9505818
• Product Code: DQY
• UDI-Device Identifier: 10801902122756
• UDI-Public: (01)10801902122756(11)240812(17)290731(10)14F24H0015(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K862056
• 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): 10/22/2025

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
• Device Catalogue Number: ES-04301
• Device Lot Number: 14F24H0015
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2024
• 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
• Patient Sex: Unknown