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	Deformation Due to Compressive Stress (2889); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported, "during the picc insertion procedure guided by ultrasound, following successful puncture with a 21g needle and ultrasound verification of intravascular guide placement, the dilator was advanced and then the peel-away introducer was inserted.At the moment of its advancement, blood was observed exiting through the upper junction between the peel-away and the introducer, accompanied by abnormal resistance and a sensation of tissue tearing.The device was immediately removed, revealing structural deformity of the peel-away (abnormal) blooming/opening of the material).The kit was replaced and the procedure continued; the peel-away advanced without complications and the catheter was then inserted.The following actions were taken: immediate suspension of the procedure upon evidence of failure, removal of the defective device, request for a new sterile kit, and catheter insertion according to protocol.No significant injury was observed in the patient.During the event, abnormal resistance and a sensation of tissue tearing were perceived; however, there was no subsequent clinical evidence of relevant vascular or tissue damage." the patient's condition was reported as fine.

• 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: 25069722
• Report Number: 9680794-2026-00340
• Device Sequence Number: 13434196
• Product Code: LJS
• UDI-Device Identifier: 10801902095388
• UDI-Public: (01)10801902095388(11)251112(17)271031(10)14F25L0105(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): 04/08/2026

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: 14F25L0105
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2025
• 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