MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8IN (50 CM; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-05052-HP
Medical Device Problem Codes	Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during initial insertion of a peripherally inserted central catheter (picc), resistance was encountered while advancing the dilator and peel-away sheath despite a dermotomy having been performed.The dilator and sheath were subsequently removed, and a microfracture at the dilator and sheath tips were observed.The device was replaced.No medical intervention was required as a result of this event.There were no reports of patient injury, harm, or adverse health consequences due to this event.The patient's condition was reported as "fine." associated mdrs include 9680794-2026-00415 and.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8IN (50 CM
• 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: 25279512
• Report Number: 9680794-2026-00416
• Device Sequence Number: 9968213
• Product Code: LJS
• UDI-Device Identifier: 10801902095388
• UDI-Public: (01)10801902095388(11)251201(17)271130(10)14F25L0164(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: PR-05052-HP
• Device Lot Number: 14F25L0164
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown