MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYSIS 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 09/01/2023

Event Type  malfunction  

Event Description

It was reported that: (b)(6) 2023, the swg was found to be kinked prior to use on the patient.There was no patient involvement.Additional information requested from the account.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: 01 sep 2023, the swg was found to be kinked prior to use on the patient.There was no patient involvement.

Manufacturer Narrative

Qn#(b)(4).The customer returned one swg without the swg assembly for evaluation.The guide wire was observed to have one kink towards the distal end of the body.The distal j-bend was slightly misshapen but intact.Signs of use were observed on the guide wire.The customer was contacted and they confirmed the defect was found prior to use and the swg was contaminated in the clinical setting.Microscopic examination confirmed the kink in the guide wire body.Both welds were present and were observed to be full and spherical.The swg advancer assembly, which protects the swg during shipment, could not be inspected as it was not returned for evaluation.The kink in the guide wire was located 49mm from the distal tip.The overall length of the guide wire measured 684mm which is within the specification of 678-688 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.848mm which is within the specification of 0.838-0.877 mm per guide wire product drawing.The guide wire was advanced through a lab inventory ars/18ga introducer needle assembly using a lab inventory swg advancer to functionally test the guide wire.The guide wire passed through both components with little to no resistance.Performed per the instructions-for-use (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 that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit warns the user , "do not use if package is damaged".The report that the guide wire kinked was confirmed through examination of the returned sample.The guide wire had one kink towards the distal end.The returned guide wire met all relevant dimensional requirements , and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire, the report that the damage was observed prior to use, and without the product packaging or swg assembly returned, the probable cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER HEMODIALYSIS 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: 17868636
• MDR Text Key: 324902175
• Report Number: 3006425876-2023-00960
• 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: 09/08/2023

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 Catalogue Number: CS-25122-F
• Device Lot Number: 71F23A1452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• 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: NOT REPORTED; NOT REPORTED.