MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ACCESS TRAY; CATHETER, PERCUTANEOUS

Catalog Number	UM-04018
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: guidewire passed through needle , it got stuck and then the needle and guidewire were removed together.When removed the wire was unravelled.The issue was identified during use on patient but there was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.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 that: guidewire passed through needle , it got stuck and then the needle and guidewire were removed together.When removed the wire was unravelled.The issue was identified during use on patient but there was no reported patient harm or consequence.
Additional Manufacturer Narrative
Qn# (b)(4).In section d provided the full udi # **udi related data quality updates only.**.
Event or Problem Description
It was reported that: guidewire passed through needle, it got stuck and then the needle and guidewire were removed together.When removed the wire was unravelled.The issue was identified during use on patient but there was no reported patient harm or consequence.

• Brand Name: ARROW ACCESS TRAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18308870
• Report Number: 9680794-2023-00997
• Device Sequence Number: 6784285
• Product Code: DQY
• UDI-Device Identifier: 10801902118889
• UDI-Public: (01)10801902118889(11)220124(17)240531(10)13F22A0432(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K810962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

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: 05/31/2024
• Device Catalogue Number: UM-04018
• Device Lot Number: 13F22A0432
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 01/04/2024; Not provided
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/04/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown