MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-24706-E

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported "the doctor found the swg kinked during use on the patient." this event occured prior to use therefor no patient harm or injury.

Event Description

It was reported "the doctor found the swg kinked during use on the patient." this event occured prior to use therefor no patient harm or injury.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Manufacturer Narrative

(b)(4).The customer returned one cvc kit with the guide wire assembly for analysis.Signs of use were observed on the guide wire.Visual analysis revealed that the guide wire contained one kink towards the middle of the body.The distal j-bend was intact.Microscopic examination confirmed the kink on the guide wire body and both welds were present and spherical.The kink measured 298mm from the proximal tip of the guide wire.The overall length of the guide wire measured 451mm, which is within the specification limits of 450mm-458mm per the guide wire product drawing.The guide wire outer diameter measured 0.795mm, which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The guide wire was advanced through a lab inventory ars and 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with minimal resistance.Performed per the instructions-for-use (ifu) statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." a manual tug test confirmed that the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this 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 report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was observed to have one kink towards the middle of the body.The returned guide wire met all relevant dimensional and functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "the doctor found the swg kinked during use on the patient." this event occured prior to use therefor no patient harm or injury.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• 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: 18806555
• MDR Text Key: 336578915
• Report Number: 3006425876-2024-00190
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: 00801902100207
• 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,Followup
• Report Date: 02/06/2024

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 Catalogue Number: CS-24706-E
• Device Lot Number: 71F22H0294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/26/2024; 05/06/2024
• Supplement Dates FDA Received: 03/27/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2022
• 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: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.