MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-22123-F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during of insertion of hd catheter, the dilator tip was found broken.The patient is fine and had no harm or injury.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during of insertion of hd catheter, the dilator tip was found broken.The patient is fine and had no harm or injury.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The customer supplied photo revealed that the tip of the dilator was deformed.The complaint of dilator tip damaged during use was able to be confirmed by the photo.However, a complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding , or component damage." 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.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 provided one photo for analysis.The complaint of dilator tip damaged during use was able to be confirmed by the photo, which revealed that the tip of the dilator was deformed.The customer also returned a cvc kit for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that the dilator tip was split/frayed.Microscopic examination confirmed the damage and revealed white stress marks, which indicate that stress was applied to the tip.The dilator was split/frayed approximately 4-5mm from the distal tip.The dilator length measured 5 3/8", which is within the specification limits of 5 1/4" - 5 3/4" per the dilator product drawing.The dilator outer diameter measured 4.00mm, which is within the specification limits of 3.97mm - 4.06mm per the dilator extrusion product drawing.The dilator inner diameter at the tip could not be accurately measured due to the damage.The returned dilator was functionally tested per the instructions for use (ifu) provided with this kit.The ifu states, "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin." a lab inventory guidewire measuring 0.85mm was used for functional testing.The dilator was inserted over the guidewire, and slight resistance was encountered at the tip.However, the entire guidewire was able to pass with some force applied.A device history record review was performed, and no relevant findings were identified.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 report of a damaged dilator tip was confirmed through investigation of the returned sample.Visual analysis revealed that the dilator tip was split/frayed.Microscopic examination confirmed the damage and revealed white stress marks.Despite the damage, the dilator met all relevant dimensional requirements , and a device history record review did not reveal any relevant findings.The root cause could not be determined; therefore, a non-conformance was initiated to further investigate this complaint.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that during of insertion of hd catheter, the dilator tip was found broken.The patient is fine and had no harm or injury.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21273828
• Report Number: 3006425876-2025-00112
• Device Sequence Number: 20853040
• Product Code: FOZ
• UDI-Device Identifier: 00801902102188
• UDI-Public: (01)00801902102188(11)241002(17)260624(10)71F24J1220(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2025

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 Expiration Date: 06/24/2026
• Device Catalogue Number: CS-22123-F
• Device Lot Number: 71F24J1220
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 03/04/2025; 02/02/2026
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/11/2025; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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