MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARTERIAL ACCESS TRAY; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04001-CK
Medical Device Problem Codes	Unsealed Device Packaging (1444); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) udi number unavailable as complaint product does not have a batch/lot number.
Event or Problem Description
It was reported that: "holes were found in packaging.Sterility was compromised.The issue was identified prior to use, there was no patient involvement." this complaint is for a large quantity of 50 devices with the same issue, identified at the same time prior to use.
Additional Manufacturer Narrative
(b)(4).The customer provided two photos for analysis.The lot number identified in one of the photos is 33f24a0390.The complaint of an improperly sealed kit was confirmed from the photos.The left side of the lidstock does not appear to have been correctly sealed to the tray.Despite this, further analysis of the tray outer lip confirmed that the adhesive was present and uniform.The packaging facility was contacted as part of this complaint investigation.They confirmed that this is a packaging defect.A device history record review was performed based on the lot# shown in the customer image (33f24a0390), and a relevant finding was identified.A non-conformance was created to address the issue of "kit not sealed properly".Further analysis revealed that this is the same failure involved in this complaint.The ifu provided with the kit informs the user, "do not use if package is damaged".The customer report of an improperly sealed kit was confirmed by visual inspection of the customer supplied photos.Visual analysis revealed that the left side of the lidstock was not adhered to the tray as intended.Based on the customer report, the customer photos, and the comments from the packaging facility, the likely root cause for this complaint is packaging related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "holes were found in packaging.Sterility was compromised.The issue was identified prior to use, there was no patient involvement." this complaint is for a large quantity of 50 devices with the same issue, identified at the same time prior to use.

• Brand Name: ARTERIAL ACCESS TRAY
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19709082
• Report Number: 9680794-2024-00672
• Device Sequence Number: 3136757
• Product Code: DQX
• UDI-Device Identifier: 00801902098269
• UDI-Public: (01)00801902098269(11)240502(17)260421(10)33F24A0390(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: 04/21/2026
• Device Catalogue Number: ASK-04001-CK
• Device Lot Number: 33F24A0390
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown