MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 16; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN922915
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Clinician alleges they were unable to remove the needle, over the spring wire guide, when attempting to remove the needle.The needle and guidewire were removed together.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire and 3-l catheter for analysis.The introducer needle was not returned for analysis.Signs of use were observed on the returned components.Visual analysis revealed the multiple offset coils in the guide wire towards the distal j-bend.The j-bend appeared misshapen but intact.Microscopic examination confirmed the defect and revealed that both welds are present and spherical.Visual analysis of the needle could not be performed as it was not returned for analysis.The offset coils in the guide wire measured 580mm and 584mm from the proximal tip.The overall length of the guide wire measured 604mm (b)(4).The outer diameter of the guide wire measured 0.79mm, (b)(4).Dimensional analysis of the introducer needle could not be performed as it was not returned for analysis.The guide wire was functionally tested per the instructions for use (ifu) provided with this kit, which states "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The guide wire was threaded through the returned catheter as well as a lab inventory introducer needle and syringe, and the guide wire passed with little to no resistance.Functional analysis of the introducer needle could not be performed as it was not returned for analysis.A manual tug test confirmed that both welds are secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." the customer report of a kinked guide wire was confirmed by investigation of the returned sample.Visual analysis revealed offset coils towards the distal j-bend.The guide wire passed all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.The appearance of the defect is consistent damage during use, but without the needle returned for analysis, the potential root cause cannot be determined.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Clinician alleges they were unable to remove the needle, over the spring wire guide, when attempting to remove the needle.The needle and guidewire were removed together.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 16
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16237254
• Report Number: 9680794-2023-00069
• Device Sequence Number: 17855503
• Product Code: FOZ
• UDI-Device Identifier: 10801902203226
• UDI-Public: 10801902203226
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/23/2023

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 Expiration Date: 04/30/2024
• Device Model Number: IPN922915
• Device Catalogue Number: ASK-42703-PB1
• Device Lot Number: 13F22K0619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown