MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN928974
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the plastic tip of the cannula is broken or cracked." another device was used.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "unknown".Associated mdr numbers include: 3006425876-2025-00578.
Additional Manufacturer Narrative
(b)(4).The customer returned one 18 ga introducer needle for analysis.Signs of use were observed on the returned component.Visual analysis revealed that the needle hub was cracked into pieces.One of the pieces was missing.The outer diameter of the needle cannula measured 0.0495", which is within the specification limits of 0.0495" 0.0505" per the cannula product drawing.The inner diameter of the needle cannula measured 0.041", which is within the specification limits of 0.041" 0.043" per cannula product drawing.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, "some disinfectants used at catheter insertion site contain solvents which can weaken the catheter material.Alcohol, acetone, and polyethylene glycol can weaken the structure of polyurethane materials.These agents' may also weaken the adhesive bond between catheter stabilization device and skin." the customer report of needle hub cracked was confirmed by visual inspection of the returned sample.Visual analysis revealed that the needle hub was cracked into pieces.The failure mode identified is consistent with the failure mode investigated per a previously opened capa.Based on the capa investigation, the root cause of this issue is design related.Teleflex has identified that this needle hub material is susceptible to cracking when placed under stress (i.E.Pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol-based disinfectants.The capa was implemented using a new alcohol-resistant material to manufacture the needle hub.The capa was implemented on 23-aug-2023 to address the issue of the cracked needle hub.This implementation date occurred after the manufacturing date of the needle hub batch (april 2023) involved with this complaint.The part number of the reported needle hub confirms this was an "old" hub material.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the plastic tip of the cannula is broken or cracked." another device was used.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "unknown".Associated mdr numbers include: 300 6425876-2025-00572 and 3006425876-2025-00578.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 22328490
• Report Number: 3006425876-2025-00572
• Device Sequence Number: 18250055
• Product Code: DQY
• UDI-Device Identifier: 40801902127714
• UDI-Public: (01)40801902127714(11)240925(17)290731(10)71F24H0852(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K862056
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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 Model Number: IPN928974
• Device Catalogue Number: CS-15703-E
• Device Lot Number: 71F24H0852
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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