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

Catalog Number	CS-15192-VFE
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: dilator failed during insertion of cvc to the right jugular vein.The plastic peeled off from the tip.There were no clinical consequences or harm reported for the patient.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: dilator failed during insertion of cvc to the right jugular vein.The plastic peeled off from the tip.There were no clinical consequences or harm reported for the patient.
Additional Manufacturer Narrative
(b)(4).The customer returned one dilator for evaluation.Signs of use were observed on the dilator body.Visual inspection of the dilator revealed plastic stretched from the dilator tip.It is unknown whether the fraying was present inside the dilator before use and was noted during use, or if the damage occurred during use.The dilator tip was not occluded, and no blockages were observed inside the body.The inner diameter of the dilator at the tip measured 0.038", which is within the specifications of 0.038-0.039" per product drawing.A lab inventory guide wire of diameter 0.038" was threaded through the returned dilator with no resistance.No blockages were observed inside the dilator body.Performed per ifu statement, "advance the dilator and sheath together with slight twisting motion over guidewire into vessel." the purchasing facility was contacted regarding this complaint issue.They indicated they had never seen this defect before, but that it would be difficult to check for such a defect while packaging the component.A device history record review was performed, and no relevant findings 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 customer report of a damaged dilator tip was confirmed through complaint investigation of the returned sample.Visual inspection revealed plastic from the dilator tip extrusion stretched outside the dilator tip.The dilator met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, and the comments from the purchasing facility, the supplier likely caused or contributed to the issue.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 RETR
• 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: 17709581
• Report Number: 9680794-2023-00633
• Device Sequence Number: 11299950
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: 10801902127171
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 08/14/2023

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: 09/30/2023
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 13F20J0756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• 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.
• Patient Sex: Unknown