MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI SET: 8.5 FR; INTRODUCER, CATHETER

Catalog Number	SI-09875-E
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one unopened psi kit for analysis.The seal along the outer edge of the lidstock was intact and uniform.Visual analysis revealed a sterility breach in the form of a small tear on the product lidstock.Microscopic examination confirmed the hole on the lidstock.No obvious damage was noted to the tray or components within the kit.It was noted that no sharp objects are present within the kit at the location of the tear.The packaging facility was consulted and they stated that as part of the production work instruction, the tray seals are 100% inspected.Additionally, the lidstock is inspected for damages.If damage is observed to the seal or the listock, the kit is discarded.Therefore, the damage likely occurred following the packaging process.The ifu provided with the kit informs the user, "do not use if package is damaged".The customer report of a sterility breach was confirmed through complaint investigation of the returned sample.Visual analysis revealed one tear on the product lidstock.The packaging facility was consulted and they stated that the kits are 100% inspected for damage to the seal and lidstock.Therefore, the damage likely occurred following the packaging process.Based on the customer description, the sample received , and complaints of this nature, storage and shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "the tyvek of the kit was found torn upon delivery.Therefore, a new kit was used instead.".

• Brand Name: ARROW PSI SET: 8.5 FR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21135438
• Report Number: 3006425876-2025-00028
• Device Sequence Number: 12464194
• Product Code: DYB
• UDI-Device Identifier: 00801902102867
• UDI-Public: (01)00801902102867(11)230905(17)270928(10)71F23H1892(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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-09875-E
• Device Lot Number: 71F23H1892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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: N/A.
• Patient Sex: Unknown