MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 4-L 8.5 FR X 16 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN915628
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "they pulled the kit and noticed the banner didn't match the label on the top of the kit".No patient involvement was reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of an incorrect product lidstock/pouch label was confirmed by visual inspection of the customer supplied video.The video showed that the banner and sticker label as part of the kit displayed that a 8.5frx16cm, 4-l catheter was included within the kit.However, the insertable lidstock displayed that the included catheter was a 7frx20cm, 3-l catheter.Additionally, the video showed that the catheter included within the kit matched the specifications of the banner/sticker label.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the video provided, packaging caused or contributed to this event.Investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "they pulled the kit and noticed the banner didn't match the label on the top of the kit".No patient involvement was reported.

• Brand Name: ARROW PI CVC KIT: 4-L 8.5 FR X 16 CM AGB
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17216576
• Report Number: 9680794-2023-00477
• Device Sequence Number: 17698161
• Product Code: FOZ
• UDI-Device Identifier: 10801902162134
• UDI-Public: 10801902162134
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/01/2023

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: 07/04/2024
• Device Model Number: IPN915628
• Device Catalogue Number: CDC-42854-XPCN1A
• Device Lot Number: 33F23B0723
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2023
• 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