MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 31 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15312-VFE
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: when the user aspirated blood from blue line of the irrigation tube with a syringe, not only blood but also air was aspirated.(no air was aspirated from red line.) it occurred to both catheters.(associated to 9680794-2023-00917).No injury to the patient was reported.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of a catheter leak was confirmed through complaint investigation of the returned sample.A leak was observed at the connection point between the juncture hub and the metal prongs.This leak likely contributed to the customer aspirating air during use.A device history record review did not reveal any relevant findings.Based on the condition of the returned device and the customer description, manufacturing caused or contributed to this event.An investigation was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: when the user aspirated blood from blue line of the irrigation tube with a syringe, not only blood but also air was aspirated.(no air was aspirated from red line.) it occurred to both catheters.(associated to 9680794-2023-00917).No injury to the patient was reported.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 31 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18208524
• Report Number: 9680794-2023-00916
• Device Sequence Number: 12612894
• Product Code: MSD
• UDI-Device Identifier: 10801902112870
• UDI-Public: 10801902112870
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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 Expiration Date: 07/31/2025
• Device Catalogue Number: CS-15312-VFE
• Device Lot Number: 13F22L0667
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2022
• 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