MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM; CATEHTER HEMODIALYSIS NON IMPL

Catalog Number CU-23122-F

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: (b)(6) 2023, the swg was found to be kinked during use on the patient.Patient condition reported as good.

Manufacturer Narrative

(b)(4).The customer returned one opened hemodialysis set with multiple components, including a guide wire in its advancer tube and an arrow raulerson syringe (ars) for evaluation.Signs of use were observed on the returned guide wire.Visual inspection of the guide wire revealed one kink on the guide wire body towards the distal end.Microscopic examination confirmed the damage.Both welds were present and appeared full and spherical.The kink in the guide wire measured 25mm from the distal end.The guide wire total length measured 602mm which is within the specifications of 596-604mm per product drawing.The guide wire outer diameter measured 0.84mm which is within the specifications of 0.838-0.877mm per product drawing.Functional inspection was performed per the instructions for use (ifu) provided with the kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was fully threaded through the returned ars and a lab inve ntory 18 ga introducer needle with minimal resistance.A manual tug test confirmed the distal and proximal welds were secure and intact.A device history record review was performed with no relevant findings.The instructions-for-use (ifu) provided with the kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished , radiographic visualization should be obtained and further consultation requested." the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed a kink in the guide wire body.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that: (b)(6) 2023, the swg was found to be kinked during use on the patient.Patient condition reported as good.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM
• Type of Device: CATEHTER HEMODIALYSIS NON IMPL
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17622089
• MDR Text Key: 321927784
• Report Number: 3006425876-2023-00826
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

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: CU-23122-F
• Device Lot Number: 71F22J0437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• 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.