MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2L 5 FR X 13 CM; CATHETER, PERCUTANEOUS

Catalog Number	CS-14502
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during central venous catheter placement in the surgery room.When the blood vessel is canalized and the metal guide is passed, it gets stuck in the needle.They were forced to remove it out of the blood vessel and when the metal guide is removed, the deformation of the metal guide is observed".
Event or Problem Description
It was reported that: "during central venous catheter placement in the surgery room.When the blood vessel is canalized and the metal guide is passed, it gets stuck in the needle.They were forced to remove it out of the blood vessel and when the metal guide is removed, the deformation of the metal guide is observed".
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided two photos for analysis.One photo showed the kit lidstock, which matches the reported finished good.The other photo shows the customer inserting the guide wire through the needle.No obvious kinking was observed.Large signs-of-use were observed inside the needle hub and on the guide wire, which can contribute to resistance encountered by the customer; however, this cannot be verified without the sample returned for analysis.Further analysis of the msk product drawing revealed that the guide wire and needle packaged within this kit does not match what is shown in the customer supplied image.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The customer report of a kinked guide wire due to needle resistance was not confirmed through visual inspection of the customer supplied photos.The photos showed the customer inserting the guide wire through the 21ga needle.Large quantities of biological material were observed, which could contribute to any resistance encountered by the customer; however, this could not be confirmed as no sample was returned for analysis.A device history record review was performed on the reported batch, and no relevant findings were identified.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.

• Brand Name: ARROW CVC SET: 2L 5 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: 19791656
• Report Number: 9680794-2024-00766
• Device Sequence Number: 12532044
• Product Code: DQY
• UDI-Device Identifier: 30801921122939
• UDI-Public: (01)30801921122939(11)230330(17)270930(10)14F23C0257(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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-14502
• Device Lot Number: 14F23C0257
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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