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

Model Number 1880,1115, 1085

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2024

Event Type  malfunction  

Event Description

Nebulizer setup for patient did not aerosolize duo neb for patient (no mrn left with defective equipment).O2 appears to make it through the tubing but does not aerosolize the medication.Setup with lot numbers/manufacturer details are in pedi leadership offices for pickup.Manufacturer response for nebulizer tubing, nebulizer tubing (per site reporter) [redacted date] sent to materials for product retrieval [redacted date] - sample retrieved; mfg notified; rma requested.

• 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: 18885447
• MDR Text Key: 337429755
• Report Number: 18885447
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1880,1115, 1085
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1