MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920513
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: " an 87-year-old female dialysis patient, who regularly attends dialysis sessions and lives independently, experienced an incident involving her chronic arrow (cannon) dialysis catheter.On (b)(6), the patient was found with bleeding due to a rupture in the arterial extension line of the catheter.The previous evening, her condition had been confirmed as stable by her home nurse.The patient has a known history of skin sensitivity and frequently scratches around the catheter site due to irritation from the dressing.Emergency services were contacted, and the hospital responded by clamping the catheter and replacing the damaged extension line.The patient is currently stable.Initial observations suggest that the damage resembles a clean-cut rather than a tear caused by pulling.".
Event or Problem Description
It was reported that: " an 87-year-old female dialysis patient, who regularly attends dialysis sessions and lives independently, experienced an incident involving her chronic arrow (cannon) dialysis catheter.On (b)(6), the patient was found with bleeding due to a rupture in the arterial extension line of the catheter.The previous evening, her condition had been confirmed as stable by her home nurse.The patient has a known history of skin sensitivity and frequently scratches around the catheter site due to irritation from the dressing.Emergency services were contacted, and the hospital responded by clamping the catheter and replacing the damaged extension line.The patient is currently stable.Initial observations suggest that the damage resembles a clean cut rather than a tear caused by pulling.".
Additional Manufacturer Narrative
(b)(4) the customer provided two photos for analysis.Both photos show the connector assembly and the cut arterial extension line.The customer also returned one connector assembly for analysis.Signs of use were observed.Visual inspection revealed a cut on the arterial extension line.No other defects or anomalies were observed on any other portion of the device.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit precautions the user, "do not use sharp instruments near extension lines or catheter." the customer report of an extension line separated/torn during use was able to be confirmed through investigation of the returned sample and customer supplied photos.Visual analysis of the sample and photos revealed a cut on the arterial extension line.The appearance of this cut is consistent with interaction with a sharp instrument, such as a needle or scalpel.No other defects or anomalies were observed on any other portion of the device.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing issue.Based on the customer report and the sample received, it was determined that unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• 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: 23520348
• Report Number: 9680794-2025-00923
• Device Sequence Number: 18558603
• Product Code: MSD
• UDI-Device Identifier: 00801902096388
• UDI-Public: (01)00801902096388(11)230125(17)271130(10)33F24M0040(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K111117
• 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): 10/20/2025

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: IPN920513
• Device Catalogue Number: CS-15282-VSP
• Device Lot Number: 33F24M0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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 Age: 87 YR
• Patient Sex: Female