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

Model Number	IPN920517
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "last week, the dialysis department encountered an incident involving a nextstep haemodialysis catheter, where air was aspirated on the extension line." the device was removed and replaced.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 provided one photo for analysis.The photo shows the kit sticker label on a customer invoice.The material#/lot# on the sticker label matches the reported finished good.The complaint of a leaking extension line was not able to be confirmed by the photo.The customer also returned one connector assembly from a retrograde hemodialysis kit.After failing functional testing, leaking was observed when flushing each arterial extension line.The leak was observed where the metal cannula meets the juncture hub of the connector assembly.Leak testing was performed per amrq-000075 rev.17, section 7.3.1, which states, "the hub or connection fitting assembly or any other part of the catheter shall not leak liquid when tested in accordance with the method given in annex c of bs en iso 10555-1".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 the arterial extension line, water was observed exiting the connection of the metal cannulas to the connector assembly.No leaks were noted when flushing the venous extension line nor any other portion of the 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.The ifu provided with the kit informs the user, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure".The ifu also states, "do not apply excessive force in placing or removing catheter or guide wire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The complaint of a leaking connector assembly was able to be confirmed through complaint investigation of the returned sample.Functional testing revealed leaking at the connection between the metal cannulas and the juncture hub when pressurizing the arterial extension line.Based on the customer report and sample received, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "last week, the dialysis department encountered an incident involving a nextstep haemodialysis catheter, where air was aspirated on the extension line." the device was removed and replaced.There was no patient harm or injury.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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20630758
• Report Number: 9680794-2024-01087
• Device Sequence Number: 20815523
• Product Code: MSD
• UDI-Device Identifier: 00801902096302
• UDI-Public: (01)00801902096302(11)240220(17)270131(10)33F23L0940(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/14/2024

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 Model Number: IPN920517
• Device Catalogue Number: CS-15232-X
• Device Lot Number: 33F23L0940
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Female