MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-21242-X1A
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "1 of the catheters was found to be defective from a kit: tip is discolored and dirty, also looks like there is a foreign object in one hole." a new kit was used to finish the procedure.There was no reported patient harm or consequence.Associated complaints 9680794-2024-00164.
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided two images for analysis.The images show discoloration of the catheter at the tip.The customer also returned one mac catheter and lidstock for analysis.No definite signs of use were observed.Visual analysis revealed a discolored white material within the skive; however, it is an intended portion of the catheter extrusion, serving as a plug.No obvious foreign material was observed within the catheter.R & d was previously contacted to provide additional clarification of the white material visible within the skive.They stated that it is a plug bonded into the extrusion to prevent blood or other fluids from entering the distal portion of the proximal lumen between the skive and the tip.It also provides strength to the extrusion so that the tipping process functions as intended.This white plug material can occasionally show through the tipped region of the blue extrusion due to the tipping process.Therefore, the material within the plug is an intended subcomponent of the assembly.The customer report of foreign material observed within the kit could not be confirmed through investigation of the returned sample.A white material was observed within the skive, but it is an intended portion of the catheter body extrusion.The white plug functions to prevent blood or other fluids from entering the distal portion of the proximal lumen between the skive and the tip.Therefore, based on the customer report , sample received, and comments from r & d, no problem was found.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that "1 of the catheters was found to be defective from a kit: tip is discolored and dirty, also looks like there is a foreign object in one hole." a new kit was used to finish the procedure.There was no reported patient harm or consequence.Associated complaints 9680794-2024-00164 and 9680794-2024-00163.

• Brand Name: ARROW MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 18684002
• Report Number: 9680794-2024-00163
• Device Sequence Number: 15264555
• Product Code: FOZ
• UDI-Device Identifier: 30801902116834
• UDI-Public: 30801902116834
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• 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): 01/16/2024

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: 05/31/2024
• Device Catalogue Number: CDC-21242-X1A
• Device Lot Number: 33F23C0451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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