MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. UNO OPTI-MIST+ NEB 210 CM (10/15) INT; NEBULIZER (DIRECT PATIETN INTERFACE)

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

It was reported by the nurse that during use with a patient, the medication in the opti-mist "bubbled" in the nebulizer; however, the treatment medication did not "atomize".No additional patient or product information could be obtained.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There was no reports of the patient harmed as a result of this malfunction.A quality complaint investigation was performed.A used sample was received to assist with the investigation.There was no lot number provided and therefore a batch record review could not be performed.However, functional testing was performed and the sample was found to have met the minimum aerosol output requirement at the lower air flow rate of 2.24m.There is not enough information to conclude the product did not meet specification and perform as intended.No further actions are required, and the complaint will be closed.No additional patient/event details have been provided to date but has been requested.Should additional information become available, a follow-up report will be submitted.Note: there are four (4) cases associated with this product complaint issue; therefore a separate fda form 3500a has been generated to address the other three (3) cases.

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 210 CM (10/15) INT
• Type of Device: NEBULIZER (DIRECT PATIETN INTERFACE)
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon secc. 4; lote 7, parque ind. del norte; reynosa, tamaulipas 88736 ; MX 88736
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4961378
• MDR Text Key: 6190197
• Report Number: 9680866-2015-00071
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• 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?: No
• 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