MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15192-VFIE
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: dilator was broken and split in front of tip portion during insertion.Patient is fine.Another device was used for the procedure.
Event or Problem Description
It was reported that: dilator was broken and split in front of tip portion during insertion.Patient is fine.Another device was used for the procedure.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." 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.
Additional Manufacturer Narrative
(b)(4).Corrected data: section h12 - corrected data section verbiage updated: section d.4.- unique identifier (udi)# corrected from (b)(4).
Event or Problem Description
It was reported that: dilator was broken and split in front of tip portion during insertion.Patient is fine.Another device was used for the procedure.
Event or Problem Description
It was reported that: dilator was broken and split in front of tip portion during insertion.Patient is fine.Another device was used for the procedure.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The photo shows a product lidstock for an antegrade hemodialysis kit.The customer returned one , opened hemodialysis kit including one, 12fr and 14fr dilator, and one, 16fr dilator from the safe sheath d-pro sheath/dilator assembly for analysis.No obvious signs of use were observed on the returned components.Visual inspection of the dilators revealed the distal tip of the 12fr appeared deformed.No defects or anomalies were observed on the other dilators.The dilator body length measured 7 7/8", which is within the specification limits of 7 3/4" - 8" per dilator product drawing.The dilator inner diameter at the distal tip could not be accurately measured due to the excess extrusion within.The dilator was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "carefully place 12 fr.Tissue dilator onto guidewire and advance to appropriate depth.A twisting motion may assist in advancing through tissue." a lab inventory 0.038" guide wire was unable to advance through the dilator tip.The sample was sent to the manufacturing facility for further investigation and it was determined that the material was likely trimmed improperly during the tipping/trimming manufacturing process.A device history record review was performed, and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit warns 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 report of a damaged dilator tip was confirmed through complaint investigation of the returned sample.Visual inspection of the dilator revealed the tip appeared deformed.The material was likely trimmed improperly during the tipping/trimming manufacturing process.Based on the sample received and comments from manufacturing, the manufacturing tipping process likely caused or contributed to the observed defect.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18854156
• Report Number: 9680794-2024-00205
• Device Sequence Number: 8282831
• Product Code: MSD
• UDI-Device Identifier: 10801902127195
• UDI-Public: 10801902127195
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/08/2024

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
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: CS-15192-VFIE
• Device Lot Number: 33F23E0773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 06/19/2024; Not provided
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 03/27/2024; 06/20/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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: NOT REPORTED; NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown