MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 1L 4FRX50CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35041-HPHNM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "within 5 days pt presented with arm swelling.Confirmation via ultrasound that patient developed dvt.Inserted by nurse, left basilic.5.1mm vessel.Lower svc tip placement confirmed via xray.0 cm external length.Patient had previous thrombus but was anticoagulated when picc was inserted.Meropenem and daptomycin infused.Pt had other device inserted on (b)(6) 2026." hematology thrombus team was called to advise for treatment.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).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date, a follow-up report will be submitted with investigation results.
Event or Problem Description
It was reported "within 5 days pt presented with arm swelling.Confirmation via ultrasound that patient developed dvt.Inserted by nurse , left basilic.5.1mm vessel.Lower svc tip placement confirmed via xray.0 cm external length.Patient had previous thrombus, but was anticoagulated when picc was inserted.Meropenem and daptomycin infused.Pt had other device inserted on 30/1/26." hematology thrombus team was called to advise for treatment.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 1L 4FRX50CM W/80CM HYDRO NIT SWG
• 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: 24454620
• Report Number: 9680794-2026-00139
• Device Sequence Number: 9969210
• Product Code: LJS
• UDI-Device Identifier: 00801902101051
• UDI-Public: (01)00801902101051(11)250401(17)270331(10)33F25A0445(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PR-35041-HPHNM
• Device Lot Number: 33F25A0445
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2025
• 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; NOT REPORTED
• Patient Sex: Unknown