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

Catalog Number	CS-25122-F
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the catheter was blocked after icu catheterization.They changed to a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required".
Event or Problem Description
It was reported that "the catheter was blocked after icu catheterization.They changed to a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required".
Additional Manufacturer Narrative
(b)(4).The reported issue of a blocked catheter was confirmed during the complaint investigation of the returned sample.The customer returned one haemodialysis 2-lumen 12 fr × 20 cm catheter.Signs of use in the form of biological material were observed in both extension lines.Visual inspection of the returned haemodialysis catheter identified biological material within both extension lines and two kinks on the catheter body; however, the customer confirmed that the kinks occurred during transportation and were not related to clinical use.Functional testing demonstrated that the proximal lumen was patent, while the distal lumen was initially obstructed.Flushing and guidewire advancement revealed that the blockage consisted of accumulated biological material, which was subsequently cleared and allowed the catheter to flush as intended.Dimensional inspection found no manufacturing-related abnormalities.Additionally, the ifu provided with this kit warns the user, "flush lumen(s) to completely clear blood from catheter.Do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.".A device history record (dhr) review showed no related nonconformances.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 23595536
• Report Number: 3006425876-2025-01073
• Device Sequence Number: 13340827
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: (01)00801902100207(11)230901(17)250712(10)71F23H1735(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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 Expiration Date: 07/12/2025
• Device Catalogue Number: CS-25122-F
• Device Lot Number: 71F23H1735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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
• Patient Sex: Unknown