MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-24703-E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A device history record review was performed, and no relevant findings were identified.
Event or Problem Description
It was reported that "open the package, the empty needle connector was loose and cannot be used." the patient was reported as fine.A different device was used to complete the procedure.The returned device showed that the issue was a crack in the needle hub.
Event or Problem Description
It was reported that "open the package, the empty needle connector was loose and cannot be used." the patient was reported as fine.A different device was used to complete the procedure.The returned device showed that the issue was a crack in the needle hub.
Additional Manufacturer Narrative
(b)(4).The customer returned multiple components of a cvc kit, including one 18ga needle, arrow raulerson syringe (ars), and guide wire assembly, for analysis.No definite signs of use were observed.Visual analysis revealed that the needle hub contained a crack in the inner surface of the luer hub.White stress marks were also observed on the needle hub.Microscopic examination confirmed the crack in the introducer needle hub.The introducer needle was functionally tested per the instructions for use (ifu) provided with this kit , which instructs the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the needle was able to attach to the returned syringe as intended and drew and aspirated water with little to no issues.The connection between the returned syringe and needle were compared with a lab inventory.The connection between the returned components was slightly looser, which may have been a result of the cracking in the needle hub.Therefore , at this time, it cannot be confirmed if the connection between the components were loose prior to the cracking.A device history record review was performed and no relevant findings were identified.The customer report of a cracked needle hub was confirmed through visual inspection of the returned sample.The needle contained one crack on the needle hub, and slight looseness was experienced between the needle hub and syringe.Cracking of the hub may contribute to the looseness experienced by the customer.The failure mode identified is consistent with the failure mode investigated per a previously opened capa.Based on the customer report and the sample received, the root cause of this complaint is design related.Teleflex has identified that the 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 fully implemented 23-aug-2023 using a new alcohol resistant material to manufacture the needle hub.The manufacturing date for the needle hub involved with this complaint occurred prior to the capa implementation date.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18775798
• Report Number: 3006425876-2024-00252
• Device Sequence Number: 4319777
• Product Code: FOZ
• UDI-Device Identifier: 00801902102287
• UDI-Public: 00801902102287
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/22/2024

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
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F22H0563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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