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 Split, Cut or Torn (4008)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "picc lumen split internally in patient".The patient had extravasation in their upper arm.There was no medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "picc lumen split internally in patient".The patient had extravasation in their upper arm.There was 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 catheter for analysis.Signs of use in the form of biological material were observed.It was noted that the catheter body was trimmed at the 36cm marking.The trimmed section was not returned for analysis.Visual analysis revealed that the catheter body was ruptured between the two and three centimeter markings.Microscopic examination confirmed the damage and revealed that the extrusion around the rupture was stretched and ballooned.Further functional analysis revealed that the rupture corresponds to the proximal extension line.When passing a lab inventory long pin gage through the proximal lumen, large quantities of congealed biological material exited the tip.The rupture measured 18mm-21mm from the juncture hub.The catheter body length from the juncture hub to the trimmed tip measured 14.375", which indicates that 5.125"-5.625" of the catheter body was trimmed and not returned for analysis per the catheter product drawing.The catheter body outer diameter measured 0.070" , which is within the specification limits of 0.066"-0.071" per the catheter extrusion product drawings.A lab inventory syringe filled with water was attached to both extension lines and flushed.When flushing the proximal line, water was observed leaking out of the rupture.Large quantities of congealed biological material were also observed exiting the lumen.No leaks were observed when flushing the distal line; however , congealed biological material was observed exiting the lumen.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, "ensure catheter patency prior to use, including prior to pressure injection.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.Power injector equipment may not prevent over pressurizing an occluded or partially occluded catheter".The ifu also states, "use only lumen(s) labeled 'pressure injectable' for pressure injection to reduce risk of catheter failure and/or patient complications.Refer to the arrow pressure injection information label for pressure injection information".The report of a ruptured catheter body was confirmed through complaint investigation.Visual and functional analysis revealed a rupture associated with the proximal extension line along the catheter body.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 for reports of this nature.

• 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: 23777124
• Report Number: 9680794-2025-01023
• Device Sequence Number: 10091825
• Product Code: LJS
• UDI-Device Identifier: 00801902101099
• UDI-Public: (01)00801902101099(11)250215(17)260331(10)33F24L0028(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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 03/31/2026
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 33F24L0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2025
• 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