MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15282-VSP
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " juncture hub leak during use on the patient." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one connector assembly, a compression fitting/cap, and compression sleeve for analysis.Signs of use in the form of biological material were observed on and within the returned components.The compression fitting/cap and compression sleeve were assembled onto the connector assembly.It was noted a portion of the catheter body was assembled within the com-pression fitting/cap on the connector assembly and appeared intentionally severed.In addition, a crack was observed on the blue venous luer hub.Leak testing was performed which states, "there shall be no liquid leakage in the form of a falling drop of water at 300-320 kpa for 30 sec when tested." both luer hubs were individually attached to the leak tester.With the distal end of the metal cannulas occluded, the extension lines were pressurized to 300 kpa for 30 seconds.When individually flushing either of the extension lines, no leaks were observed from any portion of the connector assembly.A manual tug test confirmed both the arterial and venous luer hubs were securely attached to their respective extension lines.A device history record review was performed, and no relevant findings were identified.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.Functional testing of the connector assembly did not reveal any signs of leaking from any portion of the connector assembly.Based on the customer report and sample received, no problem was found.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported " juncture hub leak during use on the patient." there was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20673957
• Report Number: 9680794-2024-01097
• Device Sequence Number: 12992480
• Product Code: MSD
• UDI-Device Identifier: 00801902096388
• UDI-Public: (01)00801902096388(11)220525(17)250430(10)13F22E0091(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111117
• 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): 10/17/2024

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
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: CS-15282-VSP
• Device Lot Number: 13F22E0091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown