MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO NIT SWG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	PR-35052-HPHNM
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "picc inserted on (b)(6) 2025.Whilst still in patient it was discovered that there was a hole/ fracture near the hub." the device was removed and replaced with a new one.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) the customer returned one, 2-lumen, pressure injectable (pi) picc for analysis.A guidewire assembly, dilator, and transduction probe were also returned.Signs-of-use in the form of biological material were observed inside and outside the catheter.Visual analysis revealed a hole in the catheter body distal to the juncture hub.Microscopic examination confirmed the damage and revealed that the extrusion around the rupture was stretched and ballooned.When passing a lab inventory long pin gage through both lumens, a blockage was observed and could not be cleared.Biological material was visually observed within both lumens from the distal tip.The hole on the catheter body measured 15mm-18mm from the juncture hub.The catheter body total length measured 13 7/8", which is not within the specification limits of 19 1/2" - 20" per the catheter product drawing.It can be assumed that between 5 5/8" and 6 1/8" was intentionally trimmed from distal end of the catheter body.The severed portion of the catheter body was not returned.The catheter body outer diameter measured 0.0695" , which is within the specification limits of 0.0690"-0.0695" per the catheter extrusion product drawing.A blockage in the proximal lumen was measured 470mm from the distal edge of the proximal luer hub.A blockage in the distal lumen was measured 271mm from the distal edge of the distal luer hub.The blockages could not be removed.A lab inventory syringe filled with water was attached to both extension lines.When flushing the distal (pink) line, fluid was observed leaking from the hole on the catheter body.No leaks were observed when flushing the proximal extension line, however it could not be flushed as a blockage was observed.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." 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 hole in the catheter body was confirmed through investigation of the returned sample.Visual and functional analysis revealed a catheter body rupture associated with the distal lumen along the catheter body.Evidence of a blockage in the distal lumen was also observed which could contribute to excessive pressure within the catheter lumen.Despite the damage, all relevant dimensional requirements were met, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, the root cause appears consistent with over-pressurization in combination with a build-up of biological material.Therefore, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "picc inserted on (b)(6) 2025.Whilst still in patient it was discovered that there was a hole/ fracture near the hub." the device was removed and replaced with a new one.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 2L 5FRX50CM W/80CM HYDRO NIT SWG
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 24428640
• Report Number: 9680794-2026-00131
• Device Sequence Number: 10227202
• Product Code: LJS
• UDI-Device Identifier: 00801902101099
• UDI-Public: (01)00801902101099(11)241115(17)260331(10)33F24J0432(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): 01/28/2026

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: 03/31/2026
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 33F24J0432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2024
• 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