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

Catalog Number	CS-15122-F
Medical Device Problem Codes	Material Invagination (1336); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the doctor checked the expiration date of the product before surgery, opened the product guidewire without obvious abnormality, the guidewire entry is not smooth during the puncture process, the guidewire is difficult to withdraw after the completion of the puncture, and the guidewire is difficult to withdraw after many times of adjusting the position and the catheter, and the guidewire is seen abnormal after the withdrawal, and it bends in many places, and there is the risk of repeated puncture, which is easy to lead to the risk of secondary injuries." the user changed to a new set.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
Event or Problem Description
It was reported "the doctor checked the expiration date of the product before surgery, opened the product guidewire without obvious abnormality, the guidewire entry is not smooth during the puncture process, the guidewire is difficult to withdraw after the completion of the puncture, and the guidewire is difficult to withdraw after many times of adjusting the position and the catheter, and the guidewire is seen abnormal after the withdrawal, and it bends in many places, and there is the risk of repeated puncture, which is easy to lead to the risk of secondary injuries." the user changed to a new set.There was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER SUBCLAVIAN
• 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: 20585531
• Report Number: 3006425876-2024-01044
• Device Sequence Number: 12905396
• Product Code: LFJ
• UDI-Device Identifier: 00801902100146
• UDI-Public: (01)00801902100146(11)230124(17)271231(10)71F23A1505(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K895417
• 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): 10/08/2024

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-15122-F
• Device Lot Number: 71F23A1505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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