MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN/PSI SET; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	SI-11142
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	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "outer transparent package damaged.Upon opening, a damaged corner was found; therefore, the device was not used to avoid contamination.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of a damaged tray was confirmed through investigation of the returned sample.The customer returned one unopened kit for analysis.One corner of the tray was bent, resulting in a crack and separation in the plastic.Visual analysis revealed a corner of the tray was bent, causing a crack and separation in the packaging.The crack created a sterility breach in the kit.Stress marks are seen on the plastic around the bent corner, which is consistent with force being applied to the tray.The packaging facility confirmed that all tray seals undergo 100% inspection prior to hood inspection, during which particulate matter, kit integrity, and component presence are fully evaluated.As the lidstock remained intact and adhered to the tray, the damage is presumed to have occurred after completion of the packaging process.A device history record review was performed, and no relevant findings were identified.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.
Event or Problem Description
It was reported that "outer transparent package damaged.Upon opening, a damaged corner was found; therefore, the device was not used to avoid contamination.".

• Brand Name: ARROW MULTILUMEN/PSI SET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24018400
• Report Number: 3006425876-2026-00072
• Device Sequence Number: 12999906
• Product Code: DYB
• UDI-Device Identifier: 00801902102898
• UDI-Public: (01)00801902102898(11)231124(17)280928(10)71F24C1541(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K002507
• 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): 12/17/2025

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-11142
• Device Lot Number: 71F24C1541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2023
• 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
• Patient Sex: Unknown