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

Catalog Number	CS-15232-VFE
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2026, during priming after completion of long-term hemodialysis catheter insertion at the hemodialysis room of (b)(6) hospital, bleeding occurred at the compression cap connection.Inspection revealed cracking on the compression cap.After confirmed with the customer.No harm for the patient.The patient condition is fine.No medical intervention was required.They changed a new one to resolve the issue.".
Additional Manufacturer Narrative
(b)(4).The reported issue of cracking on compression cap was confirmed upon investigation of the returned sample.The details of the complaint and the customer supplied pictures were reviewed.The cap was observed to be dented.The customer returned one unit of catheter body along with compression cap & sleeve interlocked together for evaluation.Minor dent was observed on the compression cap.The damage on the cap begins at seam line and deviates away at an angle.It is unknown if any excessive force was applied to this area.No abnormalities or damage noted on the rest of the body of the cap.A review of the manufacturing process confirmed that the cap undergoes relevant incoming inspection for cracks & voids.A device history record review was performed, and no relevant findings were identified.Unit was dismantled to expose the sleeve.No sleeve damage or misposition was noted.Catheter unit was functionally tested for leak.No leak observed on the dented section of the compression cap.Also, no leaks were observed from other areas of the compression cap (proximal and distal junctions).The issue was resolved with a new device.No harm noted.No medical intervention was required.Based on the customer report and the sample received, the most likely root cause is undetermined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that"(b)(6) 2026, during priming after completion of long-term hemodialysis catheter insertion at the hemodialysis room of (b)(6), bleeding occurred at the compression cap connection.Inspection revealed cracking on the compression cap.After confirmed with the customer.No harm for the patient.The patient condition is fine.No medical intervention was required.They changed a new one to resolve the issue.".

• 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: 24636721
• Report Number: 9680794-2026-00194
• Device Sequence Number: 8953491
• Product Code: PPO
• UDI-Device Identifier: 10801902195132
• UDI-Public: (01)10801902195132(11)250626(17)271125(10)33F25D0726(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/24/2026

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-15232-VFE
• Device Lot Number: 33F25D0726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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