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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the picc was only inserted on the (b)(6) 2025 and the split was noted on (b)(6) 2025 on removal as the patient was complaining of pain on flushing with all other causes ruled out." there was no patient harm or injury.No medical intervention required.The patient's current condition is unknown at this time.
Event or Problem Description
It was reported "the picc was only inserted on the (b)(6) 2025 and the split was noted on (b)(6) 2025 on removal as the patient was complaining of pain on flushing with all other causes ruled out." there was no patient harm or injury.No medical intervention required.The patient's current condition is unknown at this time.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one video for analysis.The complaint of a leaking catheter was able to be confirmed by the video; however, a complete visual inspection to evaluate the nature of the damage and determine the cause could not be performed as no sample was returned for analysis.A device history record review was performed and a potential finding was identified.As no sample was returned for investigation, it could not be determined if the finding was relevant to the reported event.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 23864669
• Report Number: 9680794-2025-01053
• Device Sequence Number: 11896961
• Product Code: LJS
• UDI-Device Identifier: 00801902101051
• UDI-Public: (01)00801902101051(11)240327(17)260228(10)33F24B0693(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): 11/27/2025

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: 02/28/2026
• Device Catalogue Number: PR-35041-HPHNM
• Device Lot Number: 33F24B0693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2024
• 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