MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC COMPONENT: 2-LUMEN 7 FR X 30 CM; CATHETER, PERCUTANEOUS

Catalog Number	HO-14702
Medical Device Problem Codes	Gas/Air Leak (2946); Incomplete or Inadequate Connection (4037); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "three way stop cock attached but was not secure.When we tried to aspirate blood, air kept getting pulled in.It turns out the white port was deformed and wasn't allowing for a complete seal.We used a different kit and the three way stop cock wouldn't attach at all to the brown port.Upon further inspection, the brown port was malformed and didn't have the threads." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "unknown".Associated mdr numbers include: 9680794-2025-00636 and 9680794-2025-00637.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided four photos for analysis.The complaint of the luer hub deformed was able to be confirmed by the photos.The proximal and distal hubs had incomplete luer hub threading which is a sign of a malfunctioning defect during the molding process.Definite signs of use were observed.Manufacturing was contacted and confirmed the issue appears to be a manufacturing defect.The luer hubs were not completely formed during the molding process.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "air embolism can occur if air is allowed to enter a central venous access device or vein.Do not leave open needles or uncapped, unclamped catheters in central venous puncture site.Use only securely tightened luer-lock connections with any central venous access device to guard against inadvertent disconnection." the customer report of the luer hub being deformed was confirmed by visual inspection of the customer supplied photos.The proximal and distal hubs had incomplete luer hub threading.Based on the customer report, photos, and comments from manufacturing, it was determined that molding was likely the root cause of this issue.A non-conformance was initiated to further investigate this complaint.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "three way stop cock attached but was not secure.When we tried to aspirate blood, air kept getting pulled in.It turns out the white port was deformed and wasn't allowing for a complete seal.We used a different kit and the three way stop cock wouldn't attach at all to the brown port.Upon further inspection, the brown port was malformed and didn't have the threads." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "unknown".Associated mdr numbers include: 9680794-2025-00636 and 9680794-2025-00637.

• Brand Name: ARROW CVC COMPONENT: 2-LUMEN 7 FR X 30 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: 22645078
• Report Number: 9680794-2025-00637
• Device Sequence Number: 15616856
• Product Code: DQY
• UDI-Device Identifier: 00801902100658
• UDI-Public: (01)00801902100658(11)250314(17)300228(10)14F25C0082(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: HO-14702
• Device Lot Number: 14F25C0082
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2025
• 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