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

Catalog Number CU-25122-F

Device Problem Obstruction of Flow (2423)

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

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Associated mdrs: 3006425876-2023-00768 and 3006425876-2023-00767.

Event Description

Customer reported "lumen blockage" during use.The user noted resistance when placing the wire through the extension line and after the catheter was placed the flow was not smooth.The device was replaced.The same problem happened on the second catheter used on the same patient.They changed to a cs-25122-f and no further issue occurred.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).Associated mdr#s 3006425876-2023-00768 and 3006425876-2023-00767.The customer returned one 2-l hemodialysis catheter and product lidstock for analysis.Signs of use in the form of biological material were observed inside the catheter extension lines.Visual analysis did not reveal any relevant defects or anomalies.The catheter body length from the juncture hub to the distal tip measured 215mm , which is within the specification limits of 207mm - 227mm per the catheter product drawing.The catheter body outer diameter measured 4.03mm, which is within the specification limits of 3.96mm - 4.06mm per the catheter extrusion product drawing.The catheter was functionally tested per the ifu, which states "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed." a lab inventory arrow raulerson syringe (ars) filled with water was attached to both extension lines and flushed.Both extension lines were able to flush as intended.No blockages were observed within the catheter.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed." the ifu also instructs the user "maintain catheter patency according to institutional policies, procedures and practice guidelines.All personnel who care for patients with central venous catheters must be knowledgeable about effective management to prolong catheter's dwell time and prevent injury." the customer report of a blocked catheter 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 relevant findings.Based on the customer report and the sample received, no problem was found with the returned sample.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

Customer reported "lumen blockage" during use.The user noted resistance when placing the wire through the extension line and after the catheter was placed the flow was not smooth.The device was replaced.The same problem happened on the second catheter used on the same patient.They changed to a cs-25122-f and no further issue occurred.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: 17538070
• MDR Text Key: 321068580
• Report Number: 3006425876-2023-00767
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902100276
• UDI-Public: 00801902100276
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K862056
• 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: 07/21/2023

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: CU-25122-F
• Device Lot Number: 71F22K2743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/13/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• 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