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

Catalog Number	CS-12122-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: " on (b)(6) 2024, in icu, the doctor found the swg kinked during use on the patient.The patient was reported as fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened, acute hemodialysis kit for analysis.The guide wire assembly will be analyzed as part of this complaint investigation.Signs-of-use in the form of biological material were observed.Visual analysis did not reveal any defects or anomalies on the returned guide wire.The guide wire length measured 600mm, which is within the specification limits of 596mm-604mm per the guide wire product drawings.The guide wire outer diameter measured 0.840mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawings.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 informs 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 of a kinked guide wire was not able to be confirmed through complaint investigation.The returned guide wire met all relevant visual and dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "(b)(6) 2024, in icu, the doctor found the swg kinked during use on the patient.The patient was reported as fine".

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19211630
• Report Number: 3006425876-2024-00406
• Device Sequence Number: 18192341
• Product Code: DQY
• UDI-Device Identifier: 00801902100108
• UDI-Public: 00801902100108
• 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): 04/01/2024

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 Expiration Date: 08/31/2026
• Device Catalogue Number: CS-12122-F
• Device Lot Number: 71F21J1163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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