MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-25142-F

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "swg kinking, difficult to advance, so cannot used to complete the procedure." no patient harm or injury.No delay to therapy.No medical intervention required.The patient's current condition is reported as "fine".

Event Description

It was reported that "swg kinking, difficult to advance, so cannot used to complete the procedure." no patient harm or injury.No delay to therapy.No medical intervention required.The patient's current condition is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The customer returned one opened kit with a guide wire assembly for analysis.The guide wire straightener tubing was returned but not attached to the assembly and the guide wire cap was not returned.Visual analysis revealed that the guide wire contained two kinks towards the distal end and a long bend on the proximal end.During full assembly, the kinks on the guide wire would have been located within the straightener tubing and cap during packaging , shipping, and storage.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were full and spherical.Additionally, definite signs of use in the form of biological material were observed on the guide wire, for which the customer provided clarification that the kinking was observed prior to use.The kinks on the guide wire 35mm, 645mm, and 661mm from the proximal weld.The guide wire total length measured 704mm, which is within the specification limits of 694mm-706mm per the guide wire product drawing.The guide wire outer diameter measure 0.944mm, which is within the specification limits of 0.94-0.965mm per the guide wire product drawing.The guide wire was inserted through a lab inventory arrow raulerson syringe (ars)/introducer needle subassembly.Little to no resistance was observed as the guide wire passed completely through the subassembly.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." a manual tug test confirmed both welds were intact.A device history record review was performed, and no relevant findings were identified.The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was kinked towards the distal end.During full assembly, the kinks on the guide wire would have been located within the straightener tubing and cap during packaging, shipping, and storage.Additionally, the guide wire passed all relevant dimensional and functional requirements.Based on these circumstances, the potential root cause cannot be determined at this time as it is unknown when the damage occurred.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19200650
• MDR Text Key: 341247185
• Report Number: 3006425876-2024-00388
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100221
• UDI-Public: 00801902100221
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

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 Catalogue Number: CS-25142-F
• Device Lot Number: 71F23D1444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED