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

Model Number IPN049251

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2020

Event Type  malfunction  

Event Description

Not able to puncture device to provide humidification.

• Brand Name: HUDSON RCI
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9720047
• MDR Text Key: 179732010
• Report Number: 9720047
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 14026704627780
• UDI-Public: (01)14026704627780
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IPN049251
• Device Catalogue Number: 037-00
• Device Lot Number: 19F110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2020
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1