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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The report that the chronic haemodialysis catheter was leaking was confirmed through investigation of the returned sample and the customer supplied photograph.The customer provided two angiograms and one photo and returned one chronic haemodialysis catheter and connector assembly.Signs of use in the form of blood particulates, yellowing of the connector assembly, and sutures on the juncture hub wings were observed.Visual inspection of the returned device revealed two small tears proximal to the catheter cuff indicative of misuse of sharps (i.E.Needles, scalpels, etc.) on the catheter.The ifu states "do not use sharp instruments near extension lines or catheter".Scuffing and damage was seen on the luer hubs and catheter body.When the compression cap was removed, the green compression sleeve was observed to be damaged.Leak testing was performed on the connector assembly and proximal portion of the returned catheter, and no leakage was observed.The distal end of the catheter body was flushed, and leakage was seen out of the small tears on the catheter body.A device history record review was performed, and no relevant findings were identified.Additional information was received that the green compression sleeve was placed incorrectly.Based on the customer report and the sample received, it was concluded that the most likely root cause is user error.
Event or Problem Description
It was reported that: "on (b)(6) 2026, the doctor found patient's tunneled catheter bleeding.The luer hub/fitting has crack and the bleeding is a different defect." associated complaints: 9680794-2026-00111 and 9680794-2026-00110.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2026, the doctor found patient's tunneled catheter bleeding.The luer hub/fitting has crack.The catheter was changed.The patient was reported as 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: 24363194
• Report Number: 9680794-2026-00111
• Device Sequence Number: 17352664
• Product Code: MSD
• UDI-Device Identifier: 00801902096333
• UDI-Public: (01)00801902096333(11)250414(17)280225(10)33F25D0125(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): 01/22/2026

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: 33F25D0125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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