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

Catalog Number	SI-09875-E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "incident occurred on (b)(6) 2025 in the room of the patient.During insertion of the swan ganz the hub of the punture needle broke.No consequence for the patient, the device was changed.".
Additional Manufacturer Narrative
(b)(4).The customer report of a cracked/separated needle hub was confirmed through complaint investigation of the customer supplied photo.The customer photo revealed a crack and a separation on the needle hub.Based on the investigation, the root cause of this complaint is design related.A capa was previously opened under teleflex quality systems to address this issue.Teleflex has identified that this needle hub material is susceptible to cracking when placed under stress (i.E.Pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol-based disinfectants.The capa was implemented using a new alcohol-resistant material to manufacture the needle hub.The needle hub from this complaint was confirmed to be manufactured prior to the capa implementation date.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "incident occurred on (b)(6) 2025 in the room of the patient.During insertion of the swan ganz the hub of the punture needle broke.No consequence for the patient, the device was changed.".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23680991
• Report Number: 3006425876-2025-01103
• Device Sequence Number: 15923199
• Product Code: DYB
• UDI-Device Identifier: 10801902219753
• UDI-Public: (01)10801902219753(11)230517(17)271130(10)71F23E0787(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/04/2025

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: 71F23E0787
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown