MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYSIS NON IMPL

Catalog Number CU-22122-F

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

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

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the doctor found the resistance between swg and ars, the swg was found kinked during used on the same patient." no medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers 3006425876-2024-00202 and 3006425876-2024-00201.

Event Description

It was reported "the doctor found the resistance between swg and ars, the swg was found kinked during used on the same patient." no medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers 3006425876-2024-00202 and 3006425876-2024-00201.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis and no damage could be confirmed from the customer provided photo.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." 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.

Manufacturer Narrative

Qn#(b)(4).The customer returned multiple components of a hemodialysis kit, including one guide wire assembly, arrow raulerson syringe (ars), introducer needle and catheter for analysis.Signs of use in the form of biological material were observed on the guide wire.Visual analysis revealed that the guide wire contained multiple kinks towards the distal end of the body.The distal j-bend was misshapen but intact.Microscopic examination confirmed the damage.The distal and proximal welds were full and spherical.No defects or anomalies were observed with the ars.The major kinks on the guide wire measured 511mm, 542mm, and 568mm from the proximal weld.The guide wire total length measured 601mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.843mm, which is within the specification limits of 0.838- 0.877mm per the guide wire product drawing.The returned ars was attached to the returned 18ga introducer needle.The guide wire was then passed through the subassembly.The undamaged portion of the guide wire was able to pass with no resistance.Minor resistance was encountered at the kinks; however, the guide wire was able to completely pass through the subassembly.Performed per 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 secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit, "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 of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was kinked towards the distal end.Resistance was experienced during functional testing due to the kinking.Despite the damage, the guide wire met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported "the doctor found the resistance between swg and ars, the swg was found kinked during used on the same patient." no medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers 3006425876-2024-00202 and 3006425876-2024-00201.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER 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: 18806570
• MDR Text Key: 336627791
• Report Number: 3006425876-2024-00191
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100252
• UDI-Public: 00801902100252
• 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 Expiration Date: 02/15/2024
• Device Catalogue Number: CU-22122-F
• Device Lot Number: 71F22B2032
• 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: 03/27/2024; 05/06/2024
• Supplement Dates FDA Received: 03/28/2024; 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2022
• 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