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

Model Number	IPN048874
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of covid, pneumonia and hypoxia.Teleflex hudson rci endotracheal tube cuff tested prior to intubation without problems.While the patient was intubated, the cuff leaked and the endotracheal tube was exchanged.Original packaging was not saved.There have been several incidents with teleflex endotracheal tubes.Listed below are additional incidents with the device.The endo tube in report above was not after a procedure.Cuff leaked air and tube exchanged.Incident reported but no tube was not after a procedure.Connector popped off 2 times.Incident reported but no tube was after a procedure.Cardiovascular surgery and then being transferred.Cuff losing air and was intubated at bedside.

• Brand Name: HUDSON RCI
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 12347805
• Report Number: 12347805
• Device Sequence Number: 19748195
• Product Code: BTR
• UDI-Device Identifier: 14026704616531
• UDI-Public: (01)14026704616531(17)260209(11)210210(10)73B2100325
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/16/2021
• Report Date (Section F): 08/16/2021

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: IPN048874
• Device Catalogue Number: 5-10116
• Device Lot Number: 73B2100325
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 88
• Date Report Sent to FDA: 08/16/2021