MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI SET: 7 FR; INTRODUCER, CATHETER

Catalog Number	SI-09700
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "cardiogenic shock, septic shock.After vascular puncture with the syringe in place, the senior physician wanted to aspirate blood.In doing so, he noticed that air was being drawn in and that the cone had come off the needle.The needle was not bent.No forceps were used with the syringe.The anatomical puncture site is the right subclavian vein.The user then used a new set.There is no patient damage due to the complained-about product.The needle is contaminated with blood.".
Event or Problem Description
It was reported that "cardiogenic shock, septic shock.After vascular puncture with the syringe in place, the senior physician wanted to aspirate blood.In doing so, he noticed that air was being drawn in and that the cone had come off the needle.The needle was not bent.No forceps were used with the syringe.The anatomical puncture site is the right subclavian vein.The user then used a new set.There is no patient damage due to the complained-about product.The needle is contaminated with blood.".
Additional Manufacturer Narrative
(b)(4).The customer provided four images for analysis.The customer complaint was confirmed by the photos, which show a separated needle hub, and the lid stock associated with the sample.The customer also returned the lid stock, needle hub, and needle cannula for investigation.Signs of use in the form of biological material were observed on and within the sample.Visual analysis revealed that the needle hub was broken and separated into 2 pieces at the distal end of the hub.A portion of the distal hub remained adhered to the needle cannula.Microscopic examination confirmed the damage.Functional inspection was not able to be performed due to the damage to the needle hub.The needle hub involved with this complaint was manufactured on 10/06/2020.A capa was fully implemented 23-aug-2023 using a new alcohol-resistant material (polycarbonate) to manufacture the needle hub.Therefore, the sample received was manufactu red prior to the implementation date of the capa.A device history record review was performed and no relevant findings were identified.The customer report of a cracked needle hub was confirmed through complaint investigation of the returned sample.Visual inspection revealed a crack on the needle hub.The failure mode identified is consistent with the failure mode investigated per a previously opened capa.Based on the capa investigation, the root cause of this complaint is design related.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.A capa was implemented using a new alcohol-resistant material to manufacture the needle hub.The implementation date of the capa occurred after the manufacturing date of the needle hub batches from this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PSI SET: 7 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: 21396235
• Report Number: 9680794-2025-00154
• Device Sequence Number: 21164129
• Product Code: DYB
• UDI-Device Identifier: 00801902101631
• UDI-Public: (01)00801902101631(11)201221(17)251130(10)14F20M0040(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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 Expiration Date: 11/30/2025
• Device Catalogue Number: SI-09700
• Device Lot Number: 14F20M0040
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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