MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW TWO-LUMEN/PSI KIT: 9 FR X 4" (10 CM); CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN037890
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "a central line was being placed in a patient and the provider was unable to advance.Upon evaluation of the catheter he discovered that the tip of it appeared defective".No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of dilator tip damaged during use was able to be confirmed by the photos.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing guidewire, dilator, or access device.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.".Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "a central line was being placed in a patient and the provider was unable to advance.Upon evaluation of the catheter he discovered that the tip of it appeared defective".No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW TWO-LUMEN/PSI KIT: 9 FR X 4" (10 CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 16616604
• Report Number: 9680794-2023-00207
• Device Sequence Number: 12330268
• Product Code: FOZ
• UDI-Device Identifier: 10801902134964
• UDI-Public: 10801902134964
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• 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): 03/01/2023

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: 03/31/2024
• Device Model Number: IPN037890
• Device Catalogue Number: ASK-21142-WHC2
• Device Lot Number: 13F22K0417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/25/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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