MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAP

Catalog Number	CDC-42703-P1A
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the guidewire was severely bent upon opening kit.No patient involvement with device was reported.
Event or Problem Description
It was reported the guidewire was severely bent upon opening kit.No patient involvement with device was reported.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The complaint of a kinked guide wire was able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.A device history record review was performed, and no relevant findings were identified.The customer report of a kinked guide wire was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, 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 MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAP
• 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: 18006341
• Report Number: 9680794-2023-00804
• Device Sequence Number: 12408650
• Product Code: FOZ
• UDI-Device Identifier: 10801902117073
• UDI-Public: 10801902117073
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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 Expiration Date: 11/24/2024
• Device Catalogue Number: CDC-42703-P1A
• Device Lot Number: 33F23B0625
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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
• Patient Sex: Unknown