MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-12122-F
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the customer returned one 18ga introducer needle and lidtock for analysis.Signs of use were observed inside the needle hub.Visual analysis revealed that the needle hub was cracked.Microscopic examination confirmed the damage.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." further investigation of this issue was performed under a previously opened capa.The capa was implemented 23-aug-2023 to address the issue of the cracked needle hub.This implementation date occurred before the manufacturing date of the needle hub batch (16-feb-2024) involved with this complaint, however, needles containing the old material were still being manufactured for kits that have yet to be converted to include the new hub material.The part number of the reported needle hub confirms this was an "old" hub material.The customer report of a cracked and separated needle hub was confirmed through complaint investigation.Visual inspection revealed a crack on the needle hub.The failure mode identified is consistent with the failure mode investigated per the previously opened capa.Based on the capa investigation, the root cause of this complaint 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.A capa was implemented using a new alcohol resistant material to manufacture the needle hub.The needle hub from this complaint was confirmed to be made from the old needle hub material.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "upon use on a patient when doctor tried to aspirate it was noticed that the introducer needle was leaking due to a crack on the needle hub.Needle removed and new set opened up to complete the procedure.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that "upon use on a patient when doctor tried to aspirate it was noticed that the introducer needle was leaking due to a crack on the needle hub.Needle removed and new set opened up to complete the procedure.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "upon use on a patient when doctor tried to aspirate it was noticed that the introducer needle was leaking due to a crack on the needle hub.Needle removed and new set opened up to complete the procedure.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 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: 21457425
• Report Number: 3006425876-2025-00202
• Device Sequence Number: 7680259
• Product Code: DQY
• UDI-Device Identifier: 00801902100108
• UDI-Public: (01)00801902100108(11)240625(17)290430(10)71F24E0130(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 02/13/2025

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 Catalogue Number: CS-12122-F
• Device Lot Number: 71F24E0130
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 06/09/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/09/2025; 06/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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