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

Catalog Number	CS-12122-F
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened hemodialysis kit for analysis.Small traces of what appears to be biological materials were observed on the dilator surface.Visual inspection revealed that the dilator tip was split and frayed.The damage appears consistent with undue force applied to the dilator during an attempted insertion.Microscopic examination confirmed the damage.The dilator total length measured 5 3/8", which is within the specifications of 5 1/4"-5 3/4" per the product drawing.The dilator inner diameter (id) at the tip could not be accurately measured due to the damage.The returned guide wire was inserted through the distal tip of the returned dilator.Minor resistance was encountered at the dilator tip due to the damage; however, the guide wire was still able to pass through the full extrusion.Performed per ifu statement, "use tissue dilator to enlarge tissue tract to the vein as required.Fol low the angle of the guidewire slowly through the skin".A device history record review was performed, and a potentially relevant finding was identified.Nc was initiated for batch to address the issue of swg/dilator resistance.Further analysis of this nc revealed that the issue in-volved the inner diameter of the dilator tip measuring out of specification.Based on the appearance of the damage involved with the sample, it has been determined that this past nc is not relevant to this investigation.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The customer report of a damaged dilator tip was confirmed through complaint investigation of the returned sample.Visual inspection revealed the dilator tip was split/frayed.The damage ap-pears consistent with undue force being applied to the dilator during an attempted insertion.The re-turned dilator met all relevant dimensional and functional require ments.Based on these circumstances and the customer report, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.Corrected data: section d.4.Unique identifier (udi)# corrected from (b)(4).
Event or Problem Description
It was reported "the doctor found the dilator hub damaged during used on the same patient." the user changed to a new set to complete the procedure.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the doctor found the dilator hub damaged during used on the same patient." the user changed to a new set to complete the procedure.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19403921
• Report Number: 3006425876-2024-00535
• Device Sequence Number: 6955923
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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 Catalogue Number: CS-12122-F
• Device Lot Number: 71F22H1988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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