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

Catalog Number CS-15192-VFE

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: according to the doctor there was a blood leakage at the junction hub after the patient was moved to the ward, after insertion.Additional information: the catheter was replaced successfully.There was no reported patient harm or consequence.

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided three photos for evaluation.The complaint of a catheter leak was not able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "establish and maintain catheter patency.Solution and frequency of flushing a venous access catheter should be established in hospital/institutional policy." the customer report of a catheter leak could not be confirmed by visual inspection of the customer supplied photos.The photos show the lidstock information and the device but no evidence of a leak was observed.In addition, full 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 probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: according to the doctor there was a blood leakage at the junction hub after the patient was moved to the ward, after insertion.Additional information: the catheter was replaced successfully.There was no reported patient harm or consequence.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR
• 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: 17860296
• MDR Text Key: 324790959
• Report Number: 9680794-2023-00734
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: 10801902127171
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 33F23B0314
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2023
• 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: NOT REPORTED.; NOT REPORTED.