MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM ANTE; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920476
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was "reported" "everything during procedure went ok but on the control x ray there is a small kink showing." there was no delay to therapy.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of a catheter kinked in use was confirmed by visual inspection of the customer supplied photo.The customer images show an x-ray of a catheter in use with a kink in the body, however, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section d.4.Unique identifier (udi)# corrected from (b)(4) to (b)(4).
Event or Problem Description
It was reported "everything during procedure went ok but on the control x ray there is a small kink showing." there was no delay to therapy.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM ANTE
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19352926
• Report Number: 9680794-2024-00487
• Device Sequence Number: 17995413
• Product Code: MSD
• UDI-Device Identifier: 10801902112801
• UDI-Public: 10801902112801
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: IPN920476
• Device Catalogue Number: CS-15232-VFIE
• Device Lot Number: 33F23G0047
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2023
• 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