MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYSIS NON IMPL

Catalog Number CU-22122-F

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported during product preparation, the doctor found foreign material inside the arrow raulerson syringe (ars) prior to patient use.The device was not used on the patient.

Manufacturer Narrative

Qn# (b)(4).The customer provided one video of the defect.In the video, a guide wire is being inserted through the syringe with resistance.The customer returned multiple components of a hemodialysis kit for analysis, including an arrow raulerson syringe (ars), introducer needle, and guidewire assembly.No definite signs of use were observed on the returned components.Initial visual analysis did not reveal any obvious defects or anomalies on the returned syringe or other components within the kit.After passing functional analysis, a loose white substance was observed within the ars handle.The ars was functionally tested per the instructions for use (ifu) provided with this kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." to identify the presence of any material within the ars, the returned guidewire was threaded through the ars.The guide wire met little to resistance.Additionally, the ars was aspirated into a beaker to identify if any foreign matter would be removed with the water.No particulate was found when aspirating the ars.R & d engineering and manufacturing were consulted as a part of this complaint investigation.Based on the appearance of the substance and the small quantity present within the ars, a positive confirmation of the material cannot be made.Additionally, it cannot be confirmed when the particulate was introduced into the kit.A device history record review was performed, and no relevant findings were identified.The customer report of a foreign material observed within the ars was confirmed by investigation of the returned sample.Visual analysis revealed a small white substance within the ars.Based on the appearance of the substance and the small quantity present within the ars, a positive confirmation of the material cannot be made.Additionally, it cannot be confirmed when the particulate was introduced into the kit.The ars passed all relevant functional testing, and a device history record review revealed no relevant findings.Based on the sample received, comments from r & d, and the complaint investigation, the potential root cause cannot be determined.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported during product preparation, the doctor found foreign material inside the arrow raulerson syringe (ars) prior to patient use.The device was not used on the patient.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER HEMODIALYSIS NON IMPL
• 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: 16134256
• MDR Text Key: 308087830
• Report Number: 3006425876-2023-00089
• Device Sequence Number: 1
• Product Code: MPB
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

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: CU-22122-F
• Device Lot Number: 71F22J3398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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