MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CV-12123-F
Medical Device Problem Codes	Component Missing (2306); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the guide wire does not progress despite the well-positioned needle with blood flowing spontaneously in 2 different places and it has significant deformation".
Additional Manufacturer Narrative
(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 that: "the guide wire does not progress despite the well-positioned needle with blood flowing spontaneously in 2 different places and it has significant deformation".
Additional Manufacturer Narrative
(b)(4) additional information received from the customer on 09-may-2025 indicates the customer reported the incorrect description of the event.Upon clarification of the description it was discovered that this is not a reportable event; thus, the initial mdr submitted on 13-feb-2025 should be retracted.
Event or Problem Description
It was reported that: "the guide wire does not progress despite the well-positioned needle with blood flowing spontaneously in 2 different places and it has significant deformation".

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21373606
• Report Number: 3006425876-2025-00152
• Device Sequence Number: 15591025
• Product Code: FOZ
• UDI-Device Identifier: 10801902122831
• UDI-Public: (01)10801902122831(11)220714(17)270630(10)71F22G1203(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K970864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2025

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-12123-F
• Device Lot Number: 71F22G1203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 03/18/2025; Not provided
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/19/2025; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown