MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX40CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-34052-HPHNM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the tip of the dilator broke off, it also broke while tearing open the peel-away sheath halfway".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2026-00035.
Additional Manufacturer Narrative
(b)(4) the actual device was not returned; however, the customer provided two photos for analysis.The complaint of a peel-away sheath tearing incorrectly was able to be confirmed by the photos.The first image shows a dilator and peel-away sheath tab that has been separated from the sheath body.A portion of the sheath body extrusion is still attached to the tab.Signs of use in the form of biological material were observed.The second image shows the remainder of the peel-away sheath during use on a patient.The sheath is partially torn with a separation of the extrusion halfway down the body.A device history record review was performed and a potential finding was identified; however, it was determined that the finding was not relevant to the reported event.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding, or component damage." the customer report of a peel-away sheath tearing incorrectly was confirmed by visual inspection of the customer supplied photos.The manufacturing facility confirmed further investigation is needed regarding the sheath body extrusion process.The root cause cannot be determined based on the available information and without a sample returned for analysis; however, a non-conformance was initiated to further investigate this issue at the manufacturing facility.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the tip of the dilator broke off, it also broke while tearing open the peel-away sheath halfway".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2026-00034 and 9680794-2026-00035.

• Brand Name: ARROW PI PICC 2L 5FRX40CM W/80CM HYDRO NIT SWG
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 23973332
• Report Number: 9680794-2026-00034
• Device Sequence Number: 8824579
• Product Code: LJS
• UDI-Device Identifier: 00801902100979
• UDI-Public: (01)00801902100979(11)250325(17)270228(10)33F25B0100(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K113277
• 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): 12/08/2025

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 Catalogue Number: PR-34052-HPHNM
• Device Lot Number: 33F25B0100
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown