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 Codes	Disconnection (1171); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: tubing disconnected from the hub of the arterial line during use on patient.When an attempt was made to twist the line back onto the hub it was noted that there was a defect, and they were unable to attach.The patient was reported as fine and there was no harm or consequence.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on a potential lot from sales history, and there were potential findings with regards to tubing torn/separated.However, without the sample returned, it could not be confirmed if the failure mode of this complaint is the same as the findings 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: tubing disconnected from the hub of the arterial line during use on patient.When an attempt was made to twist the line back onto the hub it was noted that there was a defect, and they were unable to attach.The patient was reported as fine and there was no harm or consequence.

• 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: 17815545
• Report Number: 9680794-2023-00689
• Device Sequence Number: 6069225
• 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?: Yes
• 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): Device Not Returned to Manufacturer
• 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