MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CV-15703-M
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "three arrow cvc devices were placed, however, when the guide was passed, all of them bent, making the catheter difficult to place, so multiple punctures were performed due to difficulty in passing through the guide.".The associated emdr report numbers are 9680794-2025-00264,.And 9680794-2025-00263.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The device was not returned; however, the customer provided one photo for analysis.The photo shows the kit lidstock.The finished good listed in the lidstock matches the reported finished good.The complaint of a kinked guide wire and guide wire/catheter resistance was not able to be confirmed by the photo.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested".Without the device to evaluate, 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 that "three arrow cvc devices were placed, however, when the guide was passed, all of them bent, making the catheter difficult to place, so multiple punctures were performed due to difficulty in passing through the guide.".The associated emdr report numbers are 9680794-2025-00264, 9680794-2025-00262 and 9680794-2025-00263.

• Brand Name: ARROW CVC SET: 3-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: 21719196
• Report Number: 9680794-2025-00262
• Device Sequence Number: 11708239
• Product Code: DQY
• UDI-Device Identifier: 00801902026408
• UDI-Public: (01)00801902026408(11)230216(17)280131(10)14F23B0122(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): 03/10/2025

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: CV-15703-M
• Device Lot Number: 14F23B0122
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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