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

Catalog Number CS-15242-VSP

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported "the doctor found the catheter can't through the sheath during used on the patient".No patient harm or injury.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).The report of a damaged smart seal sheath valve was confirmed through examination of the returned sample.The customer returned one, opened chronic hemodialysis kit for analysis.The peel-away sheath component will be analysed as part of this complaint investigation.Signs-of-use were observed on the sheath body.Visual analysis revealed that the sheath valve was damaged/defective.One side of the valve had separated from the hub and was lodged inside the housing.The sheath tabs were still completely connected; however, the perforated edge of the seal does not appear to align with the intended split location.Further microscopic examination revealed that the edges of the seal were smooth and uniform.The sheath tabs were intentionally split to better analyse the defective seal.Other than the separation, no obvious defects or anomalies were noted with the seal or the inside of the hub.The tabs of the sheath were intentionally split to better analyse the defective seal.It was noted that the hubs split as intended.R & d unit confirmed that the perforated line through the smartseal should run through the center of the circular opening of the tabs.This defect could restrict the passage of a catheter.Therefore, this is likely a supplier quality issue.The ifu provided with the kit informs the user, "introduce catheter through hemostasis valve/sheath and advance to desired position".A device history record review was performed, and no relevant findings were identified.Based on the condition of the sheath, the customer report, and the comments from r & d, the probable cause is supplier related since the component is purchased.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported "the doctor found the catheter can't through the sheath during used on the patient".No patient harm or injury.The patient's current condition is reported as "fine".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18658384
• MDR Text Key: 334739772
• Report Number: 9680794-2024-00086
• Device Sequence Number: 1
• Product Code: MSD
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 33F23B0749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• 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: NONE REPORTED; NONE REPORTED