MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	ASK-45552-RH
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "inserted (b)(6) 2025, discovered pink hub leaking on (b)(6) 2025.Catheter removed.They saw a pinhole.Catheter was replaced with another picc".There was no patient harm or injury.The patient's current condition is unknown at this time.
Additional Manufacturer Narrative
(b)(4).The customer returned one, 2-lumen picc catheter for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that the distal extension line contained a hole.Microscopic examination confirmed the damage and revealed that the edges were smooth and uniform, which is damage consistent with a sharp object (i.E.Scalpel, needle, suture, etc.).The extension line outer diameter measured 0.094", which is within the specification limits of 0.093"-0.097" per the distal extension line extrusion product drawing.The distal extension line inner diameter 0.057" , which is within the specification limits of 0.055"-0.059" per the distal extension line extrusion product drawing.A lab inventory syringe filled with water was attached to both extension lines and flushed.Leaking was observed from the hole on the distal extension line.Performed per ifu statement , "flush each lumen with sterile normal saline for injection to establish patency and prime lumen".A device history record review was performed, and no relevant findings were identified.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".The report of a leaking extension line was confirmed through analysis of the returned sample.Visual and functional analysis revealed leakage from a hole on the distal extension line.Microscopic examination confirmed the damage and revealed that the edges were smooth and uniform, which is damage consistent with a sharp object (i.E.Scalpel, needle, suture, etc.).Despite the damage, the sample met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24414297
• Report Number: 9680794-2026-00127
• Device Sequence Number: 5917321
• Product Code: LJS
• UDI-Device Identifier: 10801902159967
• UDI-Public: (01)10801902159967(11)250903(17)260831(10)33F25F0197(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: ASK-45552-RH
• Device Lot Number: 33F25F0197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• 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