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
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the swg was found kinked before insertion prior to the patient.They changed a new one." no patient involvement was reported therefore no paitent harm or injury.
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened hemodialysis kit including one guide wire within its advancer, an arrow raulerson syringe (ars), and an 18ga introducer needle for analysis.The guide wire straightener tube and guide wire cap were attached to each other but not to guide wire advancer.Signs of use were observed on the guide wire.The customer report suggests the defect was observed on the guide wire in a clinical setting prior to insertion into the patient; therefore, the guide wire likely became contaminated in the clinical setting.The guide wire was observed to have one kink towards the distal end of the body.The distal j-bend was not misshapen and was intact.Microscopic examination confirmed the kink in the guide wire body.Both welds were present and were observed to be full and spherical.No obvious defects or anomalies were observed on the returned tray.The kink in the guide wire measured 521 mm from the proximal tip.The overall length of the guide wire measured 601 mm which is within the specification limits of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.855 mm which is within the specification limits of 0.838-0.877 mm per guide wire product drawing.The guide wire was functionally tested per the instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through the returned ars and 18ga introducer needle.The undamaged portions of the guide wire passed through both components with little to no resistance.A manual tug test confirmed that both welds are secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu warns the user, "do not use if package is damaged.Do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." the report that the spring wire guide was kinked was confirmed through complaint investigation of the returned sample.One kink was observed towards the distal end of 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 to suggest a manufacturing related cause.The portion of the guide wire that was kinked would have been protected within the assembly tubing during packaging, storage, and shipping, so it cannot be confirmed when the guide wire was damaged.Based on these circumstances, the root cause of this investigation is undetermined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "the swg was found kinked before insertion prior to the patient.They changed a new one." no patient involvement was reported therefore no paitent harm or injury.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Common Device Name: 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: 19219905
• Report Number: 3006425876-2024-00378
• Device Sequence Number: 6904487
• Product Code: MPB
• UDI-Device Identifier: 00801902100252
• UDI-Public: 00801902100252
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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: 11/28/2024
• Device Catalogue Number: CU-22122-F
• Device Lot Number: 71F23A1287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown