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	08/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported "this was a severed arterial line.The arterial line was placed in the or and became severed in room on 8/5/23 at 00:30." the patient's condition is reported as fine.Additional information was requested but was not available at the time of this report.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of a separated tubing was confirmed through investigation of the returned sample.The customer returned the stopcock and tubing as part of the anchoring device.The entire anchoring device was not returned for analysis.No definite signs of use were observed.Visual analysis revealed that the tubing of the anchoring device was separated.The point of separation appeared smooth and uniform.Adjacent to the separation point, the tubing appeared scratched and slightly pinched.A tug test confirmed that the tubing was secure and intact within the luer hub within the stopcock.The manufacturing facility confirmed that the damage was consistent with a supplier defect.A device history record review was performed based on a potential lot from sales history and no relevant findings were identified.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Based on the customer description, sample received, and information from manufacturing facility, the supplier likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
Customer reported "this was a severed arterial line.The arterial line was placed in the operating room and became severed in room on (b)(6) 2023 at 00:30." the patient's condition is reported as fine.Additional information was requested but was not available at the time of this report.

• 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: 17691745
• Report Number: 9680794-2023-00636
• Device Sequence Number: 15081109
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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: 08/25/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/05/2023
• 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; NOT REPORTED
• Patient Sex: Unknown