MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI MULTI LUMEN CVC: 3L 7 FR X 20 CM AGB+; CATHETER, INTRAVASCULAR, THERA

Catalog Number	ASK-45703-PMM5
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the triple lumen catheter inside ask-45703-pmm5 was reported frayed upon removal." additional information received states "the metal fragment that was left behind inside of the vessel was part of the guidewire.No portion of the catheter from the first cvc kit was placed into the patient.According to the documentation, the patient was transferred to another facility where ir performed an uncomplicated removal of the retained fragment of guidewire with a snare." there was no reported clinical changes related to the procedure or retained guidewire.The patient's current condition is reported as "deceased" unrelated to the event.
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 "the triple lumen catheter inside ask-45703-pmm5 was reported frayed upon removal." additional information received states "the metal fragment that was left behind inside of the vessel was part of the guidewire.No portion of the catheter from the first cvc kit was placed into the patient.According to the documentation, the patient was transferred to another facility where ir performed an uncomplicated removal of the retained fragment of guidewire with a snare." there was no reported clinical changes related to the procedure or retained guidewire.The patient's current condition is reported as "deceased" unrelated to the event.

• Brand Name: ARROW PI MULTI LUMEN CVC: 3L 7 FR X 20 CM AGB+
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: 24378544
• Report Number: 9680794-2026-00119
• Device Sequence Number: 11977546
• Product Code: FOZ
• UDI-Device Identifier: 10801902221947
• UDI-Public: (01)10801902221947(11)250612(17)261231(10)33F25E0505(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ASK-45703-PMM5
• Device Lot Number: 33F25E0505
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2025
• 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