MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. UNO OPTI-MIST+ NEB 210CM (10/50) INT

Model Number 3772MM

Device Problem Infusion or Flow Problem (2964)

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

Event Type  malfunction  

Event Description

The nurse reports after one minute of use it was found the uno opti-mist+ neb would not 'atomize' medication.The nurse further reports the department has patients with 'very sick heart disease', however could not provide more specific details.It is also reported the patient received noninvasive ventilation due to the nebulizer device not providing 'atomized' medication.It was further reported that the device was replaced.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.No further information was available at the time of the report.Additional patient/event details have been requested.There were no reports of the patient being harmed as a result of this malfunction.Should additional information become available, a follow-up report will be submitted.

Manufacturer Narrative

Additional information: an investigation was performed on one used returned sample and no discrepancies were noted.Sample was tested to verify the minimum aerosol output at the lower flow rate.Sample met 1.5 ml minimum aerosol output requirement, it delivered 1.66 ml.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Although the sample did meet specifications, a related capa/event was leveraged to investigate nebulizer issues (poor or no mist).This complaint will remain open pending the conclusion of the investigation.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on november 23, 2015.(b)(4).

Manufacturer Narrative

Correction has been made to (patient sex) as this was submitted on the initial mdr incorrectly on 07/10/2015 due to the complaint being a general complaint and there "not being a specific patient" associated with the complaint.This information was discovered 07/13/2015.Additional information was received.Returned product was received at the manufacturing site on 07/16/2015.Updated section (device available for evaluation).Evaluation is still in progress.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on 07/27/2015.

Manufacturer Narrative

Previous investigation has been closed.Two root causes were identified.The jet was being produced in an old injection molding machine that was not conditioned with an alarm to detect and prevent the variation (double cycle) in the process.This machine has been discontinued.Inadequate inspection process for nebulizers.Corrective action has been implemented to include: verifying all active molding machines to confirm all have integrated the required alarms.Create a temporary quality alert to inspect nebulizer components every 2 hours as our inspection process is updated.Creation of a test method for inspection of molded components (nebulizer set and jet).Create a test method for inspection of molded components, clarify all details of process to do the mixing and add a form to record the amount of resin and material used in each mixing, determine water flow rates, water temperature and pressure, and include process parameters to be monitored.Determined the expected shelf life of pins for the orifice of cup and jet, and establish its replacement in the adequate period of time.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on december 29, 2015.(b)(4).

• Brand Name: UNO OPTI-MIST+ NEB 210CM (10/50) INT
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon secc. 4; lote 7, parque ind. del norte; reynosa, tams. ; MX
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4911783
• MDR Text Key: 16562027
• Report Number: 9680866-2015-00059
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K791536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3772MM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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