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 Crack (1135)

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

Event Date 04/12/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported the luer hub was found cracked during use on the patient.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported the luer hub was found cracked during use on the patient.No patient harm was reported.The patient's condition is r eported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one catheter and guide wire assembly for analysis.No definite signs of use were observed on the returned components.Visual analysis of the luer hubs revealed no cracks or scratches.No obvious defects or anomalies were noted to the other components.The outer diameter of the distal extension line measured 4.741mm which is within the specification limits of 4.70mm - 4.80mm per the extension line graphic.The inner diameter of the distal extension line measured 2.921mm , which is within the specification limits of 2.90mm - 3.00mm per the extension line graphic.The outer diameter of the proximal extension line measured 4.72mm which is within the specification limits of 4.70mm - 4.80mm per the extension line graphic.The inner diameter of the proximal extension line measured 2.921mm, which is within the specification limits of 2.90mm - 3.00mm per the extension line graphic.The catheter was functionally tested per the instructions for use (ifu) provided with this kit which instructs the user, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed." the catheter was flushed using a lab inventory syringe , and the catheter flushed as intended.A device history record review was performed and no relevant findings were identified.The ifu as part of 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." the customer report of a cracked luer hub could not be confirmed through investigation of the returned sample.The catheter passed all relevant dimensional and functional requirements, and a device history record review revealed no obvious defects or anomalies.Based on the customer report and the sample received, no problem was found on the returned device.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported the luer hub was found cracked during use on the patient.No patient harm was reported.The patient's condition is reported as fine.

• 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: 16882250
• MDR Text Key: 314727298
• Report Number: 3006425876-2023-00443
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2023

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: 02/15/2024
• Device Catalogue Number: CU-22122-F
• Device Lot Number: 71F22B2032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 05/31/2023; 09/15/2023
• Supplement Dates FDA Received: 06/05/2023; 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2022
• 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; NOT REPORTED