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

Catalog Number	CS-15232-X
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "upon insertion of the catheter there were no issues experienced and catheter was flushed and clamped however post insertion prior to applying dressing, it was noticed that the catheter / hub was 'cut'.The device was removed entirely and replaced with another set successfully.No delay in treatment.No patient complications or injury.No medical intervention".
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The customer provided one image showing the connector assembly of a hemodialysis catheter.The arterial extension line was observed to be severed.The customer returned one, connector assembly and lidstock for analysis.Signs-of-use in the form of biological material and what appears to be dried medication were observed inside the extension lines.Visual analysis revealed that the arterial extension line was severed around the middle of the extrusion.Microscopic examination confirmed the damage.The edges appear jagged but uniform.Small fractures were also observed adjacent to the separation.Analysis of the arterial pinch clamp did not reveal any defects or abnormal sharp edges.The outer diameter of the arterial extension line measured 0.1905", which is within the specification limits of 0.1850"-0.1910" per the extension line extrusion product drawing.The arterial extension line inner diameter (at the location of the separation) measured 0.122", which is within the specification limits of 0.120"-0.126" per the extension line extrusion product drawing.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage".The ifu also states, "do not use sharp instruments near extension lines or catheter".The ifu also states, "do not clamp tubing repeatedly in the same place.Doing so may weaken the tubing".The report of a separated extension line was confirmed through complaint investigation.Visual analysis revealed that the arterial extension line was severed around the middle of the extrusion.The edges of the separation appear jagged but uniform.Small fractures were also observed adjacent to the separation.Despite the damage, the sample met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report that the defect was observed "during use" and the sample received, unintentional use error likely caused or con-tributed to this event.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: section d.4.Unique identifier (udi)# corrected from(b)(4).
Event or Problem Description
It was reported that "upon insertion of the catheter there were no issues experienced and catheter was flushed and clamped however post insertion prior to applying dressing, it was noticed that the catheter / hub was 'cut'.The device was removed entirely and replaced with another set successfully.No delay in treatment.No patient complications or injury.No medical intervention".

• Brand Name: HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• 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: 19352880
• Report Number: 9680794-2024-00471
• Device Sequence Number: 12620288
• Product Code: MSD
• UDI-Device Identifier: 00801902096302
• UDI-Public: 00801902096302
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K111117
• 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): 04/24/2024

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: 05/31/2026
• Device Catalogue Number: CS-15232-X
• Device Lot Number: 33F23E0566
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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
• Patient Sex: Unknown