MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15192-X

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/07/2023

Event Type  malfunction  

Event Description

It was reported the extension line was found leaking during use on the patient.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Event Description

It was reported the extension line was found leaking during use on the patient.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer provided one image showing a connector assembly for analysis.Visual analysis revealed that the cannulas at the distal end of connector were bent and contained dents.The customer returned one, opened chronic hemodialysis kit for analysis.Signs of use in the form of biological material were observed on the catheter.Visual analysis revealed that the metal cannulas at the distal end of connector assembly were bent and dented.This damage prevented the connector assembly from being inserted into the catheter body.During functional testing (see below), the cannulas were occluded, and the extension lines were flushed using a lab inventory syringe.When flushing the arterial line, water was observed leaking at the junction of the cannula and the threads.The returned connector assembly was unable to be inserted into the catheter body due to the damage on the cannula.Functional testing was performed by occluding the distal end of cannula and flushing both extension lines with a lab inventory syringe.When flushing the arterial line, water was observed leaking at the junction between the metal cannulas and the threads.Performed per ifu statement, "securely attach irrigation tube to proximal end of catheter body.Flush each catheter lumen with sterile normal saline for injection, to establish patency and prime lumen(s) and flush the irrigation tube".Manufacturing was contacted as part of this complaint investigation.They confirmed that the connector assemblies are 100% inspected for any bending on the cannula subcomponents.They also attempted to replicate the damage during operation, but this was unsuccessful.They confirmed that this issue will need to be further investigated by their facility.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use clamps other than those that are provided.Using other clamps may damage the catheter".The report of a luer hub/fitting connection leak was confirmed through complaint investigation.Visual analysis revealed that the metal cannulas on the connector assembly were severely bent/dented.Subsequent leaking was also observed at the connection between these cannulas and the juncture hub.Manufacturing was contacted, and they confirmed that these connector assemblies are 100% inspected for any damage to the cannulas.Also, they confirmed that this bending can contribute to the observed leaking; however, it is difficult to know if the leaking was present before or after the cannulas became damaged.Therefore, the root cause for this complaint is manufacturing related so that the failure mode can be further investigated.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17645364
• MDR Text Key: 322214691
• Report Number: 9680794-2023-00619
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801902096289
• UDI-Public: 00801902096289
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111117
• 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: 08/07/2023

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-15192-X
• Device Lot Number: 13F21K0664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• 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