MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI SET: 9 FR; INTRODUCER, CATHETER

Catalog Number	SI-09903-E
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "(b)(6) 2025, the doctor found the package damaged prior to the patient." this was found prior to use.There was no patient involvement.
Event or Problem Description
It was reported that (b)(6) 2025, the doctor found the package damaged prior to the patient." this was found prior to use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The photo shows the lidstock with the top-right corner appearing to be slightly peeled open.The customer also returned one cvc kit for analysis.No obvious signs of use were observed.The corner of the tray appeared to be broken adjacent to a cavity in the tray.The original corrugate box was not returned.Visual analysis revealed the lidstock had a sterility breach in the form of the lidstock peeled back at the top-right corner of the packaging tray.The top-right corner of the tray was broken.The edges of the separation appeared rough which is consistent with undue force onto the corner of the tray resulting in the corner cracking.No signs of damage were observed on the rest of the kit nor the other components within the kit.Packaging engineers were contacted as a part of this complaint investigation.They stated the damage appears to be related to excessive storage and shipping.The packaging facility stated that the tray seals are 100% inspected prior to undergoing hood inspection where particles, kit integrity, missing components, etc.Are 100% reviewed.Since the lidstock was still attached to the broken part of the tray, this indicated the damage occurred after the packaging process.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not use if package is damaged." the customer report of a sterility breach was confirmed through investigation of the returned sample.Visual analysis revealed the product lidstock was slightly peeled open in the top-right corner of the packaging due the corner being cracked and broken.Based on the customer report and the sample received, storage and shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW PSI SET: 9 FR
• Common Device Name: INTRODUCER, 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: 22828175
• Report Number: 9680794-2025-00698
• Device Sequence Number: 15833322
• Product Code: DYB
• UDI-Device Identifier: 00801902101709
• UDI-Public: (01)00801902101709(11)240617(17)290531(10)14F24F0111(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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 Catalogue Number: SI-09903-E
• Device Lot Number: 14F24F0111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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