MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN919476
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: the dilator was split open after attempting to insert.The issue was identified during use on patient.There was no reported patient harm or consequence.
Event or Problem Description
It was reported that: the dilator was split open after attempting to insert.The issue was identified during use on patient.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The customer returned one dilator and product lidstock for analysis.Definite signs of use were observed within the distal tip.Visual analysis revealed that the distal tip was frayed and torn.The appearance of the damage is consistent with the application of undue force.The overall length of the dilator measured 5 7/16", which is within the specifications of 5 1/4"-5 3/4" per product drawing.The dilator inner diameter at the proximal end measured 1.4224mm, which is within the specifications of 1.40mm - 1.47mm per dilator graphic.The inner diameter of the dilator at the distal tip could not be measured due to the damage.Functional inspection of the dilator was performed per the instructions for use (ifu) provided with the kit which states, "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin." a lab inventory guide wire was threaded completely through the returned dilator with little to no resistance.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit instructs the user, " do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." the customer report of dilator tip damage was confirmed through investigation of the returned sample.Visual analysis revealed that the tip appeared frayed and torn.The appearance of the damage is consistent with undue force applied during an attempted insertion.Despite this, the dilator passed all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and sample received , unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: CVC SET: 3-LUMEN 12 FR X 20 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17675963
• Report Number: 3006425876-2023-00856
• Device Sequence Number: 7278723
• Product Code: FOZ
• UDI-Device Identifier: 00801902102164
• UDI-Public: 00801902102164
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K970864
• 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): 08/09/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN919476
• Device Catalogue Number: CS-15123-F
• Device Lot Number: 71F23E1517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/04/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Female