MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14402
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Easy Bruising (4558)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "an attempt was made to place the central venous catheter (cvc) initially by puncturing the right internal jugular vein under ultrasound guidance.Although venous return was obtained, the guidewire could not be advanced.Two additional attempts were made in the left internal jugular vein, without success.After repositioning the patient (hip elevation, abduction, and flexion of the extremities), and with antisepsis and a sterile field, a puncture of the left inguinal region was performed.Since the guidewire could not be passed, it was decided to make an incision medial to the femoral pulse.The left femoral vein was identified, and the 13 cm, 4fr catheter was finally inserted, with fluoroscopic confirmation of its correct position." ecchymosis was observed the previous puncture sites.There was no medical intervention required.There were no patient complications because of the ecchymosis.
Additional Manufacturer Narrative
Qn(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "an attempt was made to place the central venous catheter (cvc) initially by puncturing the right internal jugular vein under ultrasound guidance.Although venous return was obtained, the guidewire could not be advanced.Two additional attempts were made in the left internal jugular vein, without success.After repositioning the patient (hip elevation, abduction, and flexion of the extremities), and with antisepsis and a sterile field, a puncture of the left inguinal region was performed.Since the guidewire could not be passed, it was decided to make an incision medial to the femoral pulse.The left femoral vein was identified, and the 13 cm, 4fr catheter was finally inserted, with fluoroscopic confirmation of its correct position." ecchymosis was observed the previous puncture sites.There was no medical intervention required.There were no patient complications because of the ecchymosis.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 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: 22506109
• Report Number: 9680794-2025-00616
• Device Sequence Number: 8652129
• Product Code: DQY
• UDI-Device Identifier: 00801902102140
• UDI-Public: (01)00801902102140(11)230925(17)280430(10)14F23J0190(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 06/25/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: CS-14402
• Device Lot Number: 14F23J0190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• 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