MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROWG+ARD BLUE MAC TWO-LUMEN CENTRAL VENOUS ACCESS; INTRODUCER, CATHETER

Model Number	IPN035477
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A central line kit was opened by the cardiac anesthesiologist to be used for open-heart surgery.The package was opened and examined under sterile technique.Upon inspection of the catheter, it was noted the catheter was stained and one lumen was completely occluded at the catheter tip.The kit was immediately discarded, and no component touched the patient.A kit with a different lot number was opened to be used for the procedure.All remaining kits with the same lot number was taken out of the anesthesia stock room to not be used.

• Brand Name: ARROWG+ARD BLUE MAC TWO-LUMEN CENTRAL VENOUS ACCESS
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 17689530
• Report Number: 17689530
• Device Sequence Number: 6057361
• Product Code: DYB
• UDI-Device Identifier: 00801902067388
• UDI-Public: (01)00801902067388
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2023
• Report Date (Section F): 07/12/2023

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: Other
• Device Model Number: IPN035477
• Device Catalogue Number: CDC-21242-X1A
• Device Lot Number: 33F23C0451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 07/12/2023