MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 4L 8.5 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN036455
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the customer received shipment of 1 case that was labeled cdc-45854-p1a on the corragate box, however inside the case was product for ask-11142-nsu.The lidstock on the product was noted to be incorrect.No patient involvement was reported.
Additional Manufacturer Narrative
Qn# (b)(4).A total of 5 devices were reported.Associated mdr#s 9680794-2023-00460, 9680794-2023-00459, 9680794-2023-00458, 9680794-2023-00461.The customer provided three images for analysis.The images show an ask kit within a box that contains a label of a different material.The customer returned one unopened mac kit with finished good material ask-11142-nsu and lot 13f22l0806.Visual analysis revealed that the kit was returned within a box containing a label with material cdc-45854-p1a and lot 13f22l0806.The kit was opened to further analyze the components.An additional label within the kit stated that the components belonged to material cdc-45854-p1a.Additionally, the components within the kit were identified to belong to material cdc-45854-p1a.Therefore, it is determined that the product lidstock provided with the kit is incorrect.A device history record review was performed, and no relevant findings were identified.The customer report of an incorrect label was confirmed through investigation of the returned sample.A discrepancy was noted between the box label and product lidstock label.The components within the kit were observed to belong to kit with finished good cdc-45854-p1a and lot 13f22l0806, which is consistent with the box label.Therefore, based on the customer report and the sample received, product lidstock packaging likely caused or contributed to this event.A non conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW PI CVC KIT: 4L 8.5 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17122516
• Report Number: 9680794-2023-00453
• Device Sequence Number: 12620983
• Product Code: FOZ
• UDI-Device Identifier: 30801902117275
• UDI-Public: 30801902117275
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 06/09/2023

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: 03/23/2024
• Device Model Number: IPN036455
• Device Catalogue Number: CDC-45854-P1A
• Device Lot Number: 13F22L0806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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