MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15232-VFE

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: the user was unable to aspirate blood from the blue lumen during use on patient.They then removed the hub assembly and injected saline into the lumen but noted a leak between the assembly and the metal.The catheter was replaced to complete the procedure and there was no reported patient harm or consequence.

Manufacturer Narrative

Qn# (b)(4).The customer report of a catheter leak was confirmed through complaint investigation of the returned sample.The customer returned one hemodialysis catheter connector for analysis.The threaded compression sleeve, the catheter body, and the compression sleeve were not returned for analysis.After failing functional testing, a leak was observed where the metal prongs meet the juncture hub of the connector assembly.A leak test was performed on the connector assembly.With the distal ends of the metal prongs occluded, water was injected using a lab inventory 10ml syringe through each of the extension lines.When injecting water through the lumen with the red clamp, a leak was observed at the connection point between the metal prongs and the juncture hub.No leaks were observed when injecting water through the lumen with the blue extension line.The instructions-for-use (ifu) provided with the kit informs the user "ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation." a device history record review was performed with no relevant findings.Based on the condition of the returned device and the customer description, manufacturing caused or contributed to this event.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 for reports of this nature.

Event Description

It was reported that: the user was unable to aspirate blood from the blue lumen during use on patient.They then removed the hub assembly and injected saline into the lumen but noted a leak between the assembly and the metal.The catheter was replaced to complete the procedure and there was no reported patient harm or consequence.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17225102
• MDR Text Key: 318126163
• Report Number: 9680794-2023-00470
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

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-15232-VFE
• Device Lot Number: 13F22H0666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 07/19/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2022
• 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