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

Catalog Number	CS-15192-X
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "after completion of procedure, on flushing and aspiration of lumens, leakage experienced at hub assembly, despite green compression sleeve in place.Dr removed green compression sleeve and replace with the spare one in pack - still leaking on flushing and aspiration at hub assembly.Dr requested to open a cs-15232-x 23cm set to access the hub assembly, as zuid afrikaans hospital did not stock nh-15232 hub repair kit.After using new hub assembly from new pack, the catheter functioned perfectly well on flushing and aspiration of catheter lumens, no leakage." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "after completion of procedure, on flushing and aspiration of lumens, leakage experienced at hub assembly, despite green compression sleeve in place.Dr removed green compression sleeve and replace with the spare one in pack - still leaking on flushing and aspiration at hub assembly.Dr requested to open a cs-15232-x 23cm set to access the hub assembly, as (b)(6) hospital did not stock (b)(6) hub repair kit.After using new hub assembly from new pack, the catheter functioned perfectly well on flushing and aspiration of catheter lumens, no leakage." there was no patient harm or injury.No medical intervention required.The patient's current condition is 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23401778
• Report Number: 9680794-2025-00874
• Device Sequence Number: 13306998
• Product Code: MSD
• UDI-Device Identifier: 00801902096289
• UDI-Public: (01)00801902096289(11)240726(17)270630(10)33F24E0187(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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 Catalogue Number: CS-15192-X
• Device Lot Number: 33F24E0187
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2024
• 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