MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. UNO OPTIMIST + NEB KIT (50)

Model Number 3773MM

Device Problem Infusion or Flow Problem (2964)

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

Event Date 06/12/2015

Event Type  malfunction  

Event Description

The complainant reports a (b)(6) female was admitted to the emergency room with a respiratory rate in the 90's, receiving fifteen liters of oxygen per minute via a non-rebreathing oxygen mask and had a pulse oximetry reading of 93 %.It is further reported the patient was examined by a doctor twice and was diagnosed with pseudocroup, and asthmatic bronchitis and was prescribed a ventolin treatment to be delivered using the opti-mist plus nebulizer (opti-mist plus).It is further reported the first opti-mist plus sounded 'very strange', due to the medication not nebulizing the oxygen flowmeter was increased to four liters per minute which resulted in the oxygen tubing to disconnect from the nebulizer.The complainant adds this nebulizer also didn't 'atomize' so the opti-mist plus was changed to another opti-mist plus.This opti-plus also didn't 'atomize' the medication and the oxygen tubing detached from the nebulizer connection.At this time, a third opti-mist was placed on the patient which also didn't 'atomize', the oxygen tubing again detached from the nebulizer connection.A fourth opti-mist was placed.For each occurrence the oxygen tubing detached when the oxygen flowmeter was increased to 6 to 8 liters of oxygen per minute.The complainant also states it is unknown the precise liter per minute at which the oxygen tubing detached.It was reported a mask from another company worked and the patient was able to receive treatment.

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.This complaint involves four devices, therefore a separate fda form, 3500a will be drafted for each device.

Manufacturer Narrative

Additional information was received on 07/20/2015.Returned product was received at the manufacturing site.Updated (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

A quality complaint investigation was performed.Two used samples were returned to assist with the investigation.Investigation was performed.Two used samples were returned to assist with the investigation.The investigation performed by quality department of the manufacturing site indicated that product failed to meet the minimum aerosol out put (1.5 ml) requirement specified in convatec test procedure.A previous investigation is applicable to this complaint investigation and will be leveraged.This previous investigation is open.Therefore, this complaint will remain open until completion of the previous 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 07/30/2015.

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 23, 2015.(b)(4).

• Brand Name: UNO OPTIMIST + NEB KIT (50)
• 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: 4908360
• MDR Text Key: 15575311
• Report Number: 9680866-2015-00051
• 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: Other,Foreign,Health Professional,User Facility,foreign,health pr
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: 3773MM
• Device Lot Number: 105415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Date Device Manufactured: 07/01/2014
• 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
• Patient Age: 15 MO