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 11/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint reported as: "patient was undergoing catheterisation and doctor was doing procedure and after he finished the procedure, he found the leaking at hub area backron cuff area and when he tried to reopen and fix it again but also the hub is getting leaked." no patient harm was reported.A new catheter was placed.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed with one finding.For material c-30200-001 and lot 13p21a0188, a non-conformance was initiated for compression cap damaged/defective.As the sample was not returned for investigation, it cannot be determined if the non-conformance is associated with this complaint.Without the device to evaluate the complaint could not be confirmed and 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

Customer complaint reported as: "patient was undergoing catheterisation and doctor was doing procedure and after he finished the procedure, he found the leaking at hub area backron cuff area and when he tried to reopen and fix it again but also the hub is getting leaked." no patient harm was reported.A new catheter was placed.The patient's condition is reported as fine.

• 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: 16095923
• MDR Text Key: 307495726
• Report Number: 9680794-2023-00004
• Device Sequence Number: 1
• Product Code: MSD
• 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: 12/08/2022

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 Expiration Date: 05/31/2024
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 13F21J0885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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
• Patient Age: 36 YR