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
Additional Manufacturer Narrative
Qn# (b)(4).
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 9680794-2023-00916).No injury to the patient was reported.
Additional Manufacturer Narrative
(b)(4).The customer report of a leaking catheter body was confirmed through investigation of the returned sample.It was observed that the compression fitting did not completely cover the threads from the connector assembly on the returned device.Functional leak testing confirmed a leak emanating from the compression cap.The fitting was removed, and the compression sleeve was observed to be partially advanced over the threads and appeared slightly damaged.The compression sleeve and fitting were removed from the device and then reassembled per the instructions-for-use (ifu).After reassembling, the catheter assembly passed all relevant functional requirements, including leak testing.A device history record review revealed no relevant findings.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 on reports 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 9680794-2023-00916).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: 18208546
• Report Number: 9680794-2023-00917
• Device Sequence Number: 7373598
• 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
• 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