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

Catalog Number	CU-25122-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2024, the swg was found kinked during use on the patient.They were reported as fine with harm or consequence.".
Additional Manufacturer Narrative
(b)(4).The customer returned one opened hemodialysis set containing one guide wire, a catheter, and the product lidstock for evaluation.Signs-of-use were observed on the returned components, and the guide wire was returned within its advancer tube.The arrow raulerson syringe (ars) was not returned.Visual inspection of the guide wire revealed several kinks and bends throughout the body.The distal j-bend was observed to be misshapen but intact.Microscopic examination confirmed the damage.Both welds were present and appeared to be full and spherical.The major kinks in the guide wire measured 260mm and 355mm from the distal end.The guide wire total length measured 601mm which is within the specifications per product drawing.The guide wire outer diameter (od) measured 0.80mm which is within the specifications per product drawing.Functional inspection of the guide wire was performed per the product instructions-for-use (ifu)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 inserted through a lab inventory ars.The undamaged portions of the guide wire were threaded through with no resistance.A manual tug test confirmed the distal and proximal welds were intact.The guide wire product drawing was reviewed as part of this complaint investigation.The instructions-for-use (ifu) provided with the kit warns the user, "warning: do not aspirate arrow raulerson syringe while guidewire is in place; air may enter syringe through rear valve." the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed several kinks and bends throughout the guide wire body.The returned 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 contributed to this event, however, the probable cause of guide wire and ars resistance could not be determined based upon the information provided and without the ars being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "31 may 2024, the swg was found kinked during use on the patient.They were reported as fine with harm or consequence.".

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19674966
• Report Number: 3006425876-2024-00646
• Device Sequence Number: 12700613
• Product Code: DQY
• UDI-Device Identifier: 00801902100276
• UDI-Public: (01)00801902100276(11)230206(17)250112(10)71F23A2935(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2025
• Device Catalogue Number: CU-25122-F
• Device Lot Number: 71F23A2935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/04/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown