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

Catalog Number	CS-15192-VFIE
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that" (b)(6) 2026, the doctor feedback after a period of use the extension line was found deformed during used on the patient." associated complaints 9680794-2026-00236 and 9680794-2026-00238.
Additional Manufacturer Narrative
(b)(4).The reported issue that the extension line was found deformed and discoloured was confirmed upon review of customer supplied pictures.No unit was returned for evaluation.A picture was shared by the customer confirming discoloration and minor deformation of the extension lumen.The details of the complaint were reviewed.Insertion site was subclavian vein.Catheter insertion date was (b)(6) 2025.Approximately 6 months of uneventful use was seen with the catheter.No patient harm noted.Based on the additional information received, mupirocin was used as an ointment for daily disinfection.It is highly likely that the observed deformation and discoloration are associated with repeated application of mupirocin (e.G., bactroban).Prolonged daily application would be expected to result in deformation.The ifu states the following: - avoid excessive or prolonged use of alcohol-based solutions and ointments to clean catheter or site care.- clean skin around catheter using acceptable skin antiseptics.- cover exit site with sterile occlusive dressing for the entire duration of implantation.If catheter swelling is observed, discontinue use and replace catheter.- exit site and dressings must be kept clean and dry.A dhr review was completed and no relevant findings or non-conformities were noted.Based on the information, the most likely root cause of the issue is unintentional use error.
Event or Problem Description
It was reported that"06 mar 2026, the doctor feedback after a period of use the extension line was found deformed during used on the patient." associated complaints (b)(4).

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE
• 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: 24763242
• Report Number: 9680794-2026-00237
• Device Sequence Number: 9153536
• Product Code: MSD
• UDI-Device Identifier: 10801902199659
• UDI-Public: (01)10801902199659(11)231012(17)260930(10)33F23K0169(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141051
• 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): 03/09/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: CS-15192-VFIE
• Device Lot Number: 33F23K0169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• 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 Sex: Unknown