MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL ACCESS TRAY WITH .025IN SWG; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04001-BW1
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the extension tubing separated where the tubing connects with the luer lock.The issue was identified during use on patient.The patient was reported as fine.There was no patient harm.A new device was inserted.
Event or Problem Description
It was reported that: the extension tubing separated where the tubing connects with the luer lock.The issue was identified during use on patient.The patient was reported as fine.There was no patient harm.A new device was inserted.
Additional Manufacturer Narrative
(b)(4).The report of a separated/torn tubing was confirmed through complaint investigation based upon the sample received.The customer returned one tubing component from the anchoring device.Signs-of-use in the form of biological material was observed.Visual analysis revealed that the tubing was severed at the distal hub.Microscopic examination confirmed the separation.Upon functional inspection, the tubing was able to be re-inserted back into the hub; however, the connection was not secure and was able to be easily disconnected.Manufacturing unit confirmed that this was a supplier defect.The ifu provided with the kit informs the user, "do not use if package is damaged".A device history record review was performed based on sales history and a relevant finding was identified.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL ACCESS TRAY WITH .025IN SWG
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17815521
• Report Number: 9680794-2023-00688
• Device Sequence Number: 6205764
• Product Code: DQX
• UDI-Device Identifier: 10801902117585
• UDI-Public: 10801902117585
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• 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
• Report Date (Section B): 08/28/2023

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 Catalogue Number: ASK-04001-BW1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/18/2023
• 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
• Patient Sex: Unknown