MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-25122-F

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 08/16/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported the catheter was found kinked during use on the patient.The patient's condition is reported as fine.

Event Description

It was reported the catheter was found kinked during use on the patient.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned an opened hemodialysis kit, including one guide wire assembly, catheter, and product lidstock, for analysis.Definite signs of use were observed on the catheter.Visual analysis revealed that the guide wire contained multiple kinks along the body.The distal j-bend appeared misshapen but intact.Microscopic examination confirmed the damage and revealed that both welds were present and spherical.The kinks in the guide wire measured 333mm and 355mm from the proximal tip.The overall length of the guide wire measured 683 which is within the specification limits of 678mm - 688mm per the guide wire product drawing.The outer diameter measured 0.852mm which is within the specification limits of 0.838mm - 0.877mm per the guide wire product drawing.The returned guide wire was threaded through the returned catheter and a lab inventory arrow raulerson syringe (ars)/ 18ga introducer needle subassembly.The undamaged portions of the guide wire passed through the components with little to no resistance.Performed per instructions for use statement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." a manual tug test confirmed both weld were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.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 customer report of a kinked guide wire was confirmed through the investigation of the returned sample.Visual analysis confirmed multiple kinks along the guide wire body.Despite this, the guide wire passed all relevant dimensional and functional requirements, and a device history record review was performed with 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.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 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: 17984410
• MDR Text Key: 326252589
• Report Number: 3006425876-2023-01031
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: 00801902100207
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

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: 05/16/2024
• Device Catalogue Number: CS-25122-F
• Device Lot Number: 71F22F3309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• 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: NOT REPORTED; NOT REPORTED