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 Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
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 following skin dilation.The dilator and peel-away sheath were removed, and a deformity of the sheath was observed.The procedure was subsequently completed without complications.There were no reports of patient injury, harm, or adverse health consequences associated with this event.The patient's condition was reported as "fine." no additional medical intervention was required beyond removal of the affected devices.Good faith efforts were made to obtain additional information regarding the reported device issue; however, no further details were received from the user facility.

• 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: 25279823
• Report Number: 9680794-2026-00417
• Device Sequence Number: 18663376
• 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?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• 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: 06/03/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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.
• Patient Sex: Unknown