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

Model Number	IPN920475
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on (b)(6) 2025, the catheter came out, but the yellow cuff remained inside the patient.The catheter had been inserted on (b)(6) 2024.A surgical incision was successfully made to remove the cuff.The patient is well and there have been no repercussions on his state of health." associated complaints 9680794-2025-00938.
Additional Manufacturer Narrative
(b)(4).The details of the complaint were reviewed.The customer returned one unit of the catheter for evaluation.Part of the cuff material was missing.The remaining part of the material on the shaft of catheter was still bonded confirming the presence of adhesive.No other damage was noted.The ifu indicates the following- catheter removal: check catheter integrity for tears.Measure catheter when removed; it must be equal to length of catheter when inserted.Inspect for presence of entire cuff.Document the catheter removal procedure including confirmation that entire catheter length (including entire cuff and tip) has been removed per institutional policies and procedures.The additional information indicated that no sterility issues noted with the catheter during insertion.Patient had undergone a course of antibiotics for an infection a few weeks previously to the reported incident.The catheter was colonized by the same bacteria.Per the customer, the patient's comorbid diabetic condition could have led to the development of sepsis.Iv antibiotics were given.It is unknown if there was some operational technique that could have caused the cuff to separate during incision and removal.The patient is well, and no other complication observed.A new procedure was done to insert another catheter.Based on the information, the root cause of the infection and cuff separation is undeterminable.
Event or Problem Description
It was reported that: "on (b)(6) 2025, the catheter came out, but the yellow cuff remained inside the patient.The catheter had been inserted on (b)(6) 2024.A surgical incision was successfully made to remove the cuff.The patient is well and there have been no repercussions on his state of health." associated complaints 9680794-2025-00924 and 9680794-2025-00938.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23520793
• Report Number: 9680794-2025-00924
• Device Sequence Number: 15879199
• Product Code: MSD
• UDI-Device Identifier: 10801902127256
• UDI-Public: (01)10801902127256(11)240213(17)270131(10)33F24A0927(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN920475
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 33F24A0927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• 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: 11/26/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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 Age: 60 YR
• Patient Sex: Male