MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB; CATHETER, HEMODIALYSIS, NON-I

Catalog Number	CDC-25142-X1A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The full udi number is not available as complainant did not report a lot number.
Event or Problem Description
It was reported that a guidewire was found hanging out from the distal lumen of the catheter.The issue was identified on an x-ray post insertion.The guidewire appeared to have sheared.As a result, the patient was taken to interventional radiology (ir), and the guidewire was successfully removed.Additional information from the clinical staff indicated that the patient later passed away; however, the death was unrelated to this incident.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that a guidewire was found hanging out from the distal lumen of the catheter.The issue was identified on an x-ray post insertion.The guidewire appeared to have sheared.As a result, the patient was taken to interventional radiology (ir), and the guidewire was successfully removed.Additional information from the clinical staff indicated that the patient later passed away; however, the death was unrelated to this incident.

• Brand Name: ARROW HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB
• Common Device Name: CATHETER, HEMODIALYSIS, NON-I
• 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: 21333630
• Report Number: 9680794-2025-00116
• Device Sequence Number: 3826540
• Product Code: MPB
• UDI-Device Identifier: 30801902123597
• UDI-Public: (01)30801902123597(11)241031(17)251231(10)33F24J0133(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K993933
• 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): 01/22/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: CDC-25142-X1A
• Device Lot Number: 33F24J0133
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2024
• 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