MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAP

Catalog Number	CDC-45703-P1A
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "customer states that after the catheter was placed ~ 48 hours later one of the pigtails cracked and began leaking.They are not sure which pigtail." the cvc was removed.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 3-lumen cvc for analysis.Signs of use in the form of biological material were observed inside the catheter body.Visual analysis revealed a small hole on the proximal extension line.Microscopic examination confirmed the damage and revealed that the edges were smooth/uniform and angled, which is damage consistent with contact with a sharp instrument (i.E.Sutures, needle bevels, scalpels).The hole on the proximal extension line measured 67mm from the white luer hub.The proximal extension line outer diameter measured 0.086", which is within the specification limits of 0.084"-0.088" per the proximal extension line extrusion product drawing.The proximal extension line inner diameter measured 0.057", which is within the specification limits of 0.055"-0.057" per the proximal extension line extrusion product drawing.A lab inventory syringe filled with water was attached to all three extension lines and flushed.When flushing the proximal line, water was observed leaking from the hole on the extrusion.No leaks were noted when flushing the medial and distal extension lines.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".A manual tug test confirmed that all three lines were secure within the respective luer hubs.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 complaint investigation of the returned sample.Visual and functional analysis revealed a leak from a small hole on the proximal extension line.Microscopic examination revealed that the edges of the hole were smooth/uniform and angled, which is damage consistent with contact with a sharp instrument (i.E.Scalpel, scissors, 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.
Event or Problem Description
It was reported "customer states that after the catheter was placed ~ 48 hours later one of the pigtails cracked and began leaking.They are not sure which pigtail." the cvc was removed.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22144277
• Report Number: 9680794-2025-00465
• Device Sequence Number: 7372863
• Product Code: FOZ
• UDI-Device Identifier: 10801902117189
• UDI-Public: (01)10801902117189(11)240114(17)250815(10)33F24A0213(21)
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 08/15/2025
• Device Catalogue Number: CDC-45703-P1A
• Device Lot Number: 33F24A0213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2024
• 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