MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15242-VSP
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2026, the luer hub was found cracked during use on the patient.The insertion date is on (b)(6) 2025, they changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.".
Additional Manufacturer Narrative
(b)(4).The customer report of a cracked luer hub was able to be confirmed through investigation of the returned sample.The customer returned one connector assembly, compression cap, and compression sleeve for analysis.Visual analysis revealed a crack in the red arterial luer hub.Fissures due to solvent swelling were also noted on both hubs.Functional testing was performed, and no leaking was observed.This damage is consistent with damage due to alcohol exposure.Significant discoloration was observed on both hubs, with large portions of the material appearing lighter in colour.A device history record review was performed, and no relevant findings were identified.Additional information provided by the customer stated that iodophor was used to disinfect the device.Lab services were contacted, and it was determined that the discoloration is due to oxidation, potentially caused by the use of iodophor in combination with other oxidizers such as bleach-like cleaners found in clinical settings.This oxidation is unlikely to have contributed to stress-cracking and is therefore unrelated to the reported crack in the red arterial luer hub.Based on the customer report and the sample received, the root cause is likely design related.Further investigation has been initiated under teleflex quality systems to evaluate this issue.
Event or Problem Description
It was reported that: "(b)(6) 2026, the luer hub was found cracked during use on the patient.The insertion date is on (b)(6) 2025, they changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.".

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24320509
• Report Number: 9680794-2026-00101
• Device Sequence Number: 9423413
• Product Code: MSD
• UDI-Device Identifier: 00801902096333
• UDI-Public: (01)00801902096333(11)241220(17)271130(10)33F24M0039(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111117
• 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): 01/19/2026

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-15242-VSP
• Device Lot Number: 33F24M0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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 Sex: Unknown