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

Catalog Number	CS-15192-VFE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "11 apr 2025, after hemodialysis, the pinch clamp of arterial side was found broken." the user changed to a new set to resolve the issue.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).
Event or Problem Description
It was reported "(b)(6) 2025, after hemodialysis, the pinch clamp of arterial side was found broken." the user changed to a new set to resolve the issue.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).The customer submitted one photo for analysis.The photo shows the extension lines and juncture hub of a vectorflow hemodialysis catheter.A portion of the arterial pinch clamp is missing.No damage is visible to the venous extension line.The pinch clamp inserts are present and appear undamaged.The customer complaint of a pinch clamp unable to occlude was able to be confirmed from the photo.The customer returned one connector assembly for analysis.Signs of use were observed.Visual analysis revealed that the arterial pinch clamp was broken.A portion of the clamp was broken off and completely separated from the remainder of the clamp.The polymer was observed to be lighter in color and deformed around the separation points.Additionally, both the venous and arterial pinch clamp inserts were observed to be missing.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit instructs the user "examine catheter and extension lines before and after each treatment for any signs of damage." the report of a pinch clamp unable to occlude was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the red arterial pinch clamp was broken, with a portion of the clamp separated.The appearance of the damage to the clamp is consistent with damage due to undue force.Therefore, based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21959868
• Report Number: 9680794-2025-00413
• Device Sequence Number: 20649457
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: (01)10801902127171(11)240429(17)270331(10)33F24C0063(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): 04/11/2025

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
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 33F24C0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• 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.
• Patient Sex: Unknown