MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER SUBCLAVIAN

Catalog Number	CS-15122-F
Medical Device Problem Codes	Crack (1135); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the connection between the needle and syringe is cracked, making it impossible to draw water into the syringe and instead only drawing air." the user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the connection between the needle and syringe is cracked, making it impossible to draw water into the syringe and instead only drawing air." the user changed to a new set.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).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of a cracked needle hub was confirmed by the photos.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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.Do not use acetone on catheter surface.Do not use alcohol to soak catheter surface or allow alcohol to dwell in a catheter lumen to restore catheter patency or as an infection prevention measure.Do not use polyethylene glycol containing ointments at insertion site.Take care when infusing drugs with a high concentration of alcohol.Allow insertion site to dry completely prior to skin puncture and before applying dressing.Do not allow kit components to come into contact with alcohol".The customer report of a cracked needle hub was confirmed through visual inspection of the returned customer photo.The customer photo revealed that the needle hub was cracked.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 complaint is design related.Teleflex has identified that the 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 needle hub from this complaint was confirmed to be manufactured prior to the capa implementation date.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER SUBCLAVIAN
• 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: 21975969
• Report Number: 3006425876-2025-00430
• Device Sequence Number: 21150843
• Product Code: LFJ
• UDI-Device Identifier: 00801902100146
• UDI-Public: (01)00801902100146(11)231031(17)280930(10)71F23K1239(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K895417
• 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): 04/15/2025

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: CS-15122-F
• Device Lot Number: 71F23K1239
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown