MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 55 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Model Number IPN001181

Device Problem Leak/Splash (1354)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

It was reported the physician placed a 55 cm chronic dialysis set of vectorflow range on a patient via femoral access site and after hub connection was done a leakage from hub area was detected while testing the patency of arterial and venous lines.Adaptor was disassembled and reconnected and the leakage remained.Another set was opened (same product code) and the hub was replaced with no leakage.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of an insecure catheter body/connector assembly connection was not able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure." the customer report of an insecure catheter body/connector assembly connection could not be confirmed by visual inspection of the customer supplied photo.Additionally, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on a potential lot number from sales history, 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 the physician placed a 55 cm chronic dialysis set of vectorflow range on a patient via femoral access site and after hub connection was done a leakage from hub area was detected while testing the patency of arterial and venous lines.Adaptor was disassembled and reconnected and the leakage remained.Another set was opened (same product code) and the hub was replaced with no leakage.No patient harm was reported.The patient's condition is reported as fine.

Event Description

It was reported the physician placed a 55 cm chronic dialysis set of vectorflow range on a patient via femoral access site and after hub connection was done a leakage from hub area was detected while testing the patency of arterial and venous lines.Adaptor was disassembled and reconnected and the leakage remained.Another set was opened (same product code) and the hub was replaced with no leakage.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer provided one image for analysis.The image highlights the location of the catheter body/connector assembly connection point.The customer returned one chronic hemodialysis catheter assembly for analysis.No definite signs of use in the form of biological material were observed.Initial visual inspection of the connector assembly and catheter body did not reveal any defects or anomalies.The catheter assembly was disassembled to further analyze the components.The compression fitting was threaded off the connector assembly, and the green compression sleeve was observed to be partially threaded on the hub of the connector assembly.This likely contributed to the leak experienced by the customer.Additionally, after failing functional testing (see below), a leak was observed where the metal prongs meet the juncture hub of the connector assembly.The catheter was reassembled with the compression sleeve below the connector assembly threads and functionally tested.Amrq-000075 states, "there shall be no liquid leakage in the form of a falling drop of water at 300-320 kpa (43.5-46.4 psi) for 30 sec when tested per bs en iso-10555-1 annex c." prior to reassembling the catheter assembly, the luer hubs were individually connected to the leak tester and pressurized to 300kpa while the distal end of the catheter was occluded.No obvious leaking was observed at the connection between the catheter body and connector assembly.However, when flushing the venous and arterial extension lines individually, back flow was observed.A leak test was then performed on just 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 each 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.The instructions-for-use (ifu) provided with the kit instructs the user, "precaution: 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.Thread compression cap onto hub connection assembly firmly, but do not over tighten.There should be no threads visible on hub connection assembly.".The customer report of a fitting leak was confirmed through investigation of the returned sample.Functional testing revealed a leak at the connection point between the metal prongs and the juncture hub of the connector assembly.A device history record review revealed no relevant findings.Based on the customer report and the sample received, manufacturing likely caused or contributed to this event.A non conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 55 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: 17286656
• MDR Text Key: 318785718
• Report Number: 9680794-2023-00489
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10801902112726
• UDI-Public: 10801902112726
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN001181
• Device Catalogue Number: CS-15552-VFE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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; NOT REPORTED