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

Model Number 3772MM

Device Problem Improper Flow or Infusion (2954)

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

Event Date 06/07/2015

Event Type  malfunction  

Event Description

The nurse reports medication in the opti-mist nebulizer 'bubbled' however they did not 'atomize'.The nurse further reports there was no harm to the patient.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.This complaint involves an unknown number devices.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 becomes available, a follow-up report will be submitted.

Manufacturer Narrative

A quality complaint investigation was performed.One used sample was returned to assist with the investigation.The investigation performed by quality department of the manufacturing site indicated that product met the minimum aerosol output requirements at the lower air flow rate.It delivered 2.24ml.The evaluation of one used returned sample, indicated that no discrepancies were found.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.No further actions are required, and the complaint will be closed.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 august 04, 2015.

Manufacturer Narrative

Additional information was received to clarify complaint details on (b)(6) 2015."the nurse could not remember the " story" about these specific products, because they have had so many defective nebulizers, so they just threw them away, but they kept some, because they have the serious case." additional information was received on july 20, 2015.Returned product was received at the manufacturing site on (b)(4) 2015.Evaluation of this product is no longer required.The product was received and unable to be evaluated.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 july 24, 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.(b)(4).

• Brand Name: UNO OPTI-MIST+ NEB 210CM (10/50) INT
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon secc. 4; lote 7, parque ind. del norte; reynosa, tams. 88736 ; MX 88736
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4881539
• MDR Text Key: 6048740
• Report Number: 9680866-2015-00038
• 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: 06/15/2015

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: 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
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 06/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/24/2015; 08/04/2015; 12/28/2015
• 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