MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CV-25703-E
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: when clinician opened the package the guide wire was bent.The device was not used on patient.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The photo shows a kinked guide wire; however, the guide wire assembly was not pictured.The customer also returned an opened cvc kit including a 3-lumen catheter, 18ga introducer needle, and dilator for analysis.The guide wire was not returned.Visual analysis of the returned kit and its components did not reveal any defects or anomalies.Visual inspection of the guide wire could not be performed as the guide wire was not returned.A device history record review was performed and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product warns the user, "do not use if package is damaged.".The report that the guide wire kinked during use was confirmed through visual analysis of the customer supplied photo.The customer photo shows a kinked guide wire; however, the guide wire was not returned.A device history record review did not identify any manufacturing related issues.The probable cause of the guide wire damage cannot be determined based on the information provided and without the guide wire being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: when clinician opened the package the guide wire was bent.The device was not used on patient.There was no reported patient harm or consequence.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 19059004
• Report Number: 3006425876-2024-00336
• Device Sequence Number: 6631411
• Product Code: FOZ
• UDI-Device Identifier: 10801902029390
• UDI-Public: 10801902029390
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/13/2024

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 Expiration Date: 06/23/2024
• Device Catalogue Number: CV-25703-E
• Device Lot Number: 71F22F6847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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