MAUDE Adverse Event Report: TELEFLEX INCORPORATED HUDSON RCI; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	IPN049251
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Not able to puncture device to provide humidification.

• Brand Name: HUDSON RCI
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9720047
• Report Number: 9720047
• Device Sequence Number: 352798
• Product Code: CAF
• UDI-Device Identifier: 14026704627780
• UDI-Public: (01)14026704627780
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/31/2020
• Report Date (Section F): 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: IPN049251
• Device Catalogue Number: 037-00
• Device Lot Number: 19F110
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/31/2020