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 cateter 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.

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

(b)(4).Associated mdr#s 3006425876-2023-00768 and 3006425876-2023-00767.The customer report of a blocked catheter was confirmed through investigation of the returned sample.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.Initial visual analysis did not reveal any relevant defects or anomalies.After performing functional testing, large quantities of congealed biological material were observed the catheter.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 manufacturing product drawing.The catheter body outer diameter measured 4.05mm, which is within the specification limits of 3.96mm - 4.06mm per the catheter extrusion manufacturing 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 flushed, and minor resistance was experienced, but the lines were able to flush as intended.Large amounts of congealed biomaterial were observed when flushing both extension lines, which likely contributed to the blockage experienced by the customer.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 catheter passed all relevant dimensional and functional requirements.A device history record review was performed, and no relev ant findings were identified.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 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17538062
• MDR Text Key: 321068552
• Report Number: 3006425876-2023-00768
• 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