MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM PICC 2L 5.5FRX55CM 130CM HYDR NIT SWG; INTRODUCER, CATHETER

Catalog Number	PR-45552-HPHNL
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during picc procedure, the peel-away sheath became kinked while being advanced into the vessel." the procedure was successfully completed using a different device.There was no medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported that "during picc procedure, the peel-away sheath became kinked while being advanced into the vessel." the procedure was successfully completed using a different device.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned a set containing a picc, dust caps, and a catheter trimmer for analysis.No definite signs of use were observed on any of the components.The peel-away sheath associated with this complaint was not returned.Therefore, a visual inspection of the reported sheath could not be performed.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 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." based on the customer report and without the sheath returned for analysis, the potential root cause cannot be determined at this time.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW AM PICC 2L 5.5FRX55CM 130CM HYDR NIT SWG
• Common Device Name: INTRODUCER, CATHETER
• 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: 24815486
• Report Number: 9680794-2026-00271
• Device Sequence Number: 20336356
• Product Code: OFC
• UDI-Device Identifier: 10801902215793
• UDI-Public: (01)10801902215793(11)250411(17)260930(10)33F25D0076(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: PR-45552-HPHNL
• Device Lot Number: 33F25D0076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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