MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-24402
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the procedure according to ifu, the md found the guide wire to be faulty.So the md opend up the new kit to finish the procedure." the returned device was found to be kinked.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of a kinked guide wire was confirmed through investigation of the returned sample.The guide wire was kinked in multiple locations, of which most of the kinked locations would be protected by the guide wire and straightener tubing.Despite this, the guide wire passed all relevant dimensional and functional requirements.Based on the customer report, comments from manufacturing, and circumstances of the sample received, it cannot be confirmed when the guide wire became kinked.Therefore, the potential root cause is undetermined at this time.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that "during the procedure according to ifu, the md found the guide wire to be faulty.So the md opened up the new kit to finish the procedure." the returned device was found to be kinked.There was no reported patient harm or consequence.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18675477
• Report Number: 3006425876-2024-00188
• Device Sequence Number: 7338527
• Product Code: FOZ
• UDI-Device Identifier: 00801902102249
• UDI-Public: 00801902102249
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/08/2024

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 Catalogue Number: CS-24402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Female