MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-21142-XCN1A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "our risk department instructed staff to deliver unopened packages to the microbiology department for culturing.The samples in question were from two kits of the same lot number.Upon culturing, the results showed the presence of ralstonia insidiosa in one of the kits.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "our risk department instructed staff to deliver unopened packages to the microbiology department for culturing.The samples in question were from two kits of the same lot number.Upon culturing, the results showed the presence of ralstonia insidiosa in one of the kits.".
Additional Manufacturer Narrative
(b)(4).Visual inspection could not be performed as the actual samples were not returned for analysis.In order to evaluate the customer reported issue, bioburden testing was performed on returned sterile representative samples.These samples were subjected to microbiological (bioburden) testing, including evaluation for aerobic organisms, yeast, and mold.No microbial growth was detected in any of the samples tested.A review of manufacturing and sterilization records was also performed for the associated lots.The products were manufactured in an iso-classified cleanroom environment with routine environmental monitoring.All environmental conditions remained within established control limits during production.Additionally, bioburden and endotoxin testing conducted during manufacturing demonstrated results below detection limits, indicating effective control of microbial contamination prior to sterilization.The sterilization process was also reviewed and confirmed to be validated using an overkill methodology in accordance with applicable iso 11135 standards.This approach provides a substantial margin of safety and ensures the effectiveness of the sterilization cycle, including against environmentally resistant organisms.There is no historical evidence of contamination events associated with the manufacturing site.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 if package is damaged." the customer report of a sterility issue could not be confirmed based on testing performed on representative samples as well as a review of manufacturing and sterilization parameters for the reported batch(es).The customer did not return the complaint samples; however, several sterile representative samples were returned from the same batch as well as adjacent batches distributed to this customer.These samples were subjected to microbiological (bioburden) testing, including evaluation for aerobic organisms, yeast, and mold.No microbial growth was detected in any of the samples tested.A review of manufacturing and sterilization records was also performed for the associated lots which demonstrated results below detection limits , indicating effective control of microbial contamination prior to sterilization.The sterilization process was also reviewed and confirmed to be validated using an overkill methodology in accordance with applicable iso 11135 standards.Based on these circumstances, the cause of the customer reported issue could not be determined.Teleflex will continue to monitor and trend reports of this nature.

• Brand Name: ARROW MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• 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: 21824209
• Report Number: 9680794-2025-00288
• Device Sequence Number: 15823192
• Product Code: FOZ
• UDI-Device Identifier: 10801902179262
• UDI-Public: (01)10801902179262(11)240806(17)260425(10)33F24E0254(21)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: 04/25/2026
• Device Catalogue Number: CDC-21142-XCN1A
• Device Lot Number: 33F24E0254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2024
• 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