MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICROMIST NEB W/ADULT MASK&TBG, SM VOL; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 41893

Device Problem Infusion or Flow Problem (2964)

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

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Complaint reported as: "when using atrodual (ipratropiumbromidi/salbutamol) with a nebulizer mask, the mask does not vaporize the drug properly even with the full flow of oxygen and the bottle of oxygen.Oxygen was not able to flow properly in the mask and very little steam was formed.It took a long time for the patient to get all the medicine inhaled.".

• Brand Name: HUDSON MICROMIST NEB W/ADULT MASK&TBG, SM VOL
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 9111958
• MDR Text Key: 191742611
• Report Number: 3004365956-2019-00251
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2019

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
• Device Operator: No Information
• Device Catalogue Number: 41893
• Device Lot Number: 191126
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1