MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO NIT SWG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	PR-35052-HPHNM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "operating room reported a damaged/torn rubber tip, failed to insert during use." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one, opened kit for analysis.Signs of use were observed on the sheath and dilator.Visual analysis revealed that the distal end of the peel-away sheath tip was damaged.It was also noted that the peel-away was split adjacent to the tabs.It is assumed that this occurred due to customer handling after observing the damage to the tip.The sheath length from the tabs to the distal tip measured 4" , which is within the specification limits of 3 7/8"-4 1/8" per peel-away product drawing.The sheath outer diameter measured 0.0955", which is within the specification limits of 0.0940"-0.0990" per peel-away extrusion product drawing.The sheath inner diameter could not be measured at the distal or proximal ends due to the condition of the returned sample.Functional analysis could not be performed due to the condition of the returned sample.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 report of peel-away body damage was confirmed through visual analysis of the returned sample.Visual analysis revealed that the sheath tip was damaged.Despite the damage, the sheath and the dilator met all relevant functional requirements.Various factors could contribute to the observed damage to the sheath tip , including the sheath tip manufacturing process and/or undue force applied unintentionally by the user; therefore, the root cause is undetermined.A non-conformance was initiated to further investigate potential root causes at the manufacturing site.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "operating room reported a damaged/torn rubber tip, failed to insert during use." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO NIT SWG
• 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: 24293355
• Report Number: 9680794-2026-00095
• Device Sequence Number: 21385681
• Product Code: LJS
• UDI-Device Identifier: 00801902101099
• UDI-Public: (01)00801902101099(11)250619(17)270428(10)33F25D0024(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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-35052-HPHNM
• Device Lot Number: 33F25D0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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