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

Catalog Number	CS-15232-VFE
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer provided three photos for investigation.The complaint of sheath tears incorrectly can be confirmed from the second and third photos as they reveal an irregular tear pattern in the sheath that is not across the score lines as intended.The customer also returned one sheath for investigation.Visual inspection of the sheath also confirmed that it was torn incorrectly.One tab became completely separated from the extrusion with a portion of the extrusion still molded onto it.It was also noted that the entire sheath extrusion was torn.Microscopic examination confirmed the damage and revealed that the point of tearing was irregular and not along the intended score lines.Functional testing could not be performed due to the condition of the returned sample.A device history record review was performed with one relevant finding.Two non-conformances for material c-70013-003 and lots 33p23k0339 , 33p23k0340 were initiated for peel away sheath tears incorrectly.The instructions for use (ifu) provided with this kit states "introduce catheter through hemostasis valve/sheath and advance to desired position.Sharply snap the tabs of valve housing in a plane perpendicular to the long axis of sheath to split valve and split sheath apart while withdrawing from vessel." the customer report of a sheath tearing incorrectly was confirmed by a complaint investigation of the returned sample.The returned sheath did not separate along the score lines as intended.The sheath is manufactured by a third party supplier; therefore, the supplier caused or contributed to this defect.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "during the insertion of the catheter, when the peel-away sheath was being removed, the medical staff had to cut the distal tip with scissors to be able to remove it.The insertion was completed and no breach was observed on the catheter inserted." there was no reported patient harm or consequence.

• Brand Name: HEMODIALYSIS SET: 2-L 15 FR X 23 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19307742
• Report Number: 9680794-2024-00463
• Device Sequence Number: 12595897
• Product Code: MSD
• UDI-Device Identifier: 10801902127256
• UDI-Public: 10801902127256
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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-15232-VFE
• Device Lot Number: 33F23K0176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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.
• Patient Sex: Unknown