MAUDE Adverse Event Report: TELEFLEX INCORPORATED HUDSON RCI; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	IPN048896
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A powder like substance was found at the top of the tube after opening the sterile package & prior to patient contact.

• Brand Name: HUDSON RCI
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 17423685
• Report Number: 17423685
• Device Sequence Number: 17631225
• Product Code: BTR
• UDI-Device Identifier: 14026704616753
• UDI-Public: (01)14026704616753(17)280309(11)230310(10)73C2300322
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 06/30/2023
• Report Date (Section F): 07/05/2023

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: Health Professional
• Device Model Number: IPN048896
• Device Catalogue Number: 5-10315
• Device Lot Number: 73C2300322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 07/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2023
• 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: Unknown
• Date Report Sent to FDA: 07/05/2023