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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the doctor found the luer hub/fiting connection leaked during used on the patient.No harm for the patient." the user changed to a new set.There was no medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the doctor found the luer hub/fiting connection leaked during used on the patient.No harm for the patient." the user changed to a new set.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened cannon ii plus chronic hemodialysis kit including one threaded extension line (c-30038-001a) and the irrigation tube (c-30038-001a ) for analysis.The connector assembly (j-71524-001a) was not returned.Visual analysis did not reveal any defects or anomalies on the threaded extension line.Leak testing was performed per the product instructions-for-use (ifu) which states , "flush each catheter lumen with sterile normal saline for injection, to establish patency and prime lumen(s)." a lab inventory syringe filled with water was used flush the irrigation tube with the distal end occluded.No leaks or blockages were observed.A manual tug test confirmed the luer hub was securely attached to the extension line.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user, "securely attach irrigation tube to proximal end of catheter body.Flush each catheter lumen with sterile normal saline for injection, to establish patency and prime lumen(s) and flush the irrigation tube.Examine catheter and extension lines before and after each treatment for any signs of damage.Do not use sharp instruments near extension lines or catheter.Repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure." the complaint of a leaking connector assembly was not able to be confirmed through complaint investigation of the returned sample.The connector assembly was not returned.Functional testing of the returned irrigation tube did not reveal any signs of leaking.A device history record review was performed, and no relevant findings were identified.Based on the sample received, the probable cause cannot be determined without the connector assembly returned for analysis.Teleflex will continue to monitor and trend on complaints 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: 20212096
• Report Number: 9680794-2024-00926
• Device Sequence Number: 7327905
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: (01)10801902127171(11)230628(17)260531(10)33F23E0776(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): 08/26/2024

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 Expiration Date: 05/31/2026
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 33F23E0776
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown