MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EASIVENT MASK; NEBULIZER (DIRECT PATIENT INTERFACE)

Catalog Number 20701

Device Problem Gas/Air Leak (2946)

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

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

A sample was received to perform an investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A visual inspection found that the device was assembled correctly and did not show any visual defects.Functional testing of the unit found that it had an air leak.A whistle sound was not confirmed during testing.The root cause of the air leak could not be determined.No corrective actions are planned at this time.Smiths-medical regularly analyzes complaint data and trends and will take further actions accordingly.Complaint data will be regularly analyzed and further actions will be taken accordingly.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.

Event Description

It was reported that upon use, the mask was making a whistle sound when taking medication.Additional information indicated that the medication could be heard seeping out.No patient injury was reported.

• Brand Name: PORTEX EASIVENT MASK
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15415131
• MDR Text Key: 305889958
• Report Number: 3012307300-2022-19041
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 20701
• Device Lot Number: 3884688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1