MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ACCESS TRAY; SALINE VASCULAR ACCESS FLUSH

Catalog Number	ASK-04001-VCUH3
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath and dilator for analysis.Signs of use in the form of biological material were observed on the dilator body and within the sheath.Visual analysis revealed that the sheath body was crimped/deformed on one blue score line.The overall length of the sheath measured 2 13/16" which is within the specification limits of 2 5/8" - 2 7/8" per the sheath product drawing.The sheath outer diameter measured 0.09735", which is within the specification limits of 0.091" - 0.101" per the sheath product drawing.The sheath inner diameter at the distal tip measured 0.074", which is within the specification limits of 0.074" - 0.075" per the sheath product drawing.The returned dilator was able to be removed and re-inserted through the sheath with little to no issue.Performed per ifu statement, "check peel-away sheath placement by holding sheath in place, twist dilator hub counterclockwise to release dilator hub from sheath hub, withdraw guidewire and dilator sufficiently to allow blood flow".A device history record review was performed and a finding was identified.A non-conformance was created for part number eb-01051-002 with lot 34c24a0308 regarding peel-away sheath tears incorrectly.At this time, it cannot be determined if this finding is relevant to the reported event.The customer report of a peel away sheath body damage was confirmed through investigation of the returned sample.Visual analysis revealed a deformation/crimping in the sheath extrusion towards the middle of the body.No obvious damage was observed to the sheath tip.Despite this, the sheath passed all relevant dimensional and functional requirements.Based on the customer report and sample received, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported "the peel away buckled in the middle of the sheath, it was not a difficult insertion and the clinician is very skilled and familiar with "choking up" on the sheath and advancing in small increments.They had to replace the sheath with another single sterile but they were able to complete the procedure without further incident." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW ACCESS TRAY
• Common Device Name: SALINE VASCULAR ACCESS FLUSH
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20428283
• Report Number: 9680794-2024-00995
• Device Sequence Number: 7589569
• Product Code: NGT
• UDI-Device Identifier: 10801902214895
• UDI-Public: (01)10801902214895(11)240311(17)250731(10)33F24A1438(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K192414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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: 07/31/2025
• Device Catalogue Number: ASK-04001-VCUH3
• Device Lot Number: 33F24A1438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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: NONE REPORTED.
• Patient Sex: Male