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

Model Number IPN920475

Device Problems Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

It was reported that "after inserting the catheter and putting on the replacement hub, the staff discovered that it was leaking.The staff had to take the replacement hub from the new set and complete the procedure.".

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

Qn# (b)(4).The customer report of a fitting leak was confirmed through investigation of the returned sample.The customer provided one image an d returned one chronic hemodialysis connector assembly, compression cap, and product lidstock for analysis.No definite signs-of-use in the form of biological material were observed.Initial visual inspection of the connector assembly and compression cap and did not reveal any defects or anomalies.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 blue extension line, a leak was observed at the connection point between the metal prongs and the juncture hub.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, manufacturing likely caused or contributed to this event.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 reports of this nature.

Event Description

It was reported that "after inserting the catheter and putting on the replacement hub, the staff discovered that it was leaking.The staff had to take the replacement hub from the new set and complete the procedure.".

• 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: 18254652
• MDR Text Key: 329555026
• Report Number: 9680794-2023-00930
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10801902127256
• UDI-Public: 10801902127256
• Combination Product (y/n): N
• Reporter Country Code: LO
• 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: 11/08/2023

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 Operator: Health Professional
• Device Model Number: IPN920475
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 33F23F0720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• 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.