MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CV-17702-E
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the catheter was punctured along its length." additional information received from the customer states there was "a hole in the extension".The device was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "hemodynamically stable".
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-l cvc, ars, dilator, guidewire, arrow advancer, dust caps, and a box clamp for analysis.Signs of use were observed on the catheter body and inside the extension lines.Visual inspection of the catheter revealed a small slit on the catheter body, at the location of the double line marking following the juncture hub.No damage or defects were observed to either of the extension lines or luer hubs.The only visible damage was the slit on the catheter body.The appearance of the damage was consistent with contact with a sharp object (e.G.Needle , scalpel, scissors, etc.) during use.The slit in the catheter body was measured 18mm from the juncture hub.The catheter body length from the juncture hub to the distal tip measured 215mm , which is within the specifications of 207mm - 227mm per catheter product drawing.The catheter body outer diameter measured 0.0951", which is within the specifications of 0.094" - 0.098" per catheter extrusion product drawing.The inner diameter of the catheter tip measured 0.9906mm, which is within the specifications of 0.95mm - 1.02mm per catheter product drawing.Functional inspection of the returned catheter was performed per the product ifu which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen (s)." both extension lines were individually flushed using a lab inventory 10 ml syringe.When flushing from the distal extension line, no defects or anomalies were observed, and it flushed as intended.When flushing from the proximal extension line, water was observed exiting the hole in the catheter body.A manual tug test confirmed the distal and proximal luer hubs were attached to their respective extension lines.A device history record review was performed, and one relevant finding was identified; however, it was determined that the finding was relevant to the reported event.The instructions for use (ifu) provided with the kit warns 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 customer report of a catheter body puncture in use was confirmed through complaint investigation of the returned sample.Visual inspection revealed a small hole on the catheter body near the proximal end, whose appearance was consistent with contact with a sharp object during use.The returned catheter met all relevant dimensional requirements, and a device history record review was performed with no evidence to suggest a manufacturing issue.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "the catheter was punctured along its length." additional information received from the customer states there was "a hole in the extension".The device was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "hemodynamically stable".

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 21824602
• Report Number: 9680794-2025-00303
• Device Sequence Number: 4288514
• Product Code: DQY
• UDI-Device Identifier: 00801902105455
• UDI-Public: (01)00801902105455(11)220919(17)270831(10)14F22J0128(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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 Catalogue Number: CV-17702-E
• Device Lot Number: 14F22J0128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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