MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OPTI-MIST PLUS NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 3773MM

Device Problem No Flow (2991)

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

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the "when the nurse connected the product with the oxygen tube and wanted to start the treatment of the patient, the mask did not nebulize".It was further reported that "it makes a wheezing sound and no "dust" comes out like normally".

Manufacturer Narrative

Additional information: a quality investigation was performed.Based on the examination of batch records the product was manufactured according to specification.Although there is not enough information to conclude the product did not meet specification and perform as intended, there is a previous investigation applicable for the type of nebulizer issues reported in the current complaint.The previous investigation is still pending; therefore, this complaint will remain open until completion of the investigation.A sample was expected but not received.The investigation will be updated once the complaint sample is received and evaluated.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Previous investigation leveraged for this complain and the investigation is completed.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).

Manufacturer Narrative

This supplemental report is being submitted as the results of the investigation indicated that the possible product affected by non conformity under this investigation was produced in an old injection machine which had not the technology to detect and prevent a failure like a double cycle.That machine has been discontinued and it is not in use anymore.Inspection process for nebulizers should be reviewed / improved to increase its level of confidence to detect any failure or variation in the equipment and process.A corrective action was initiated to address the manufacturing quality inconsistencies and additional training initiatives were implemented for the operators.The non conformance has been closed.Therefore this complaint can be closed and no further actions are required.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 (b)(6) 2016.(b)(4).

• Brand Name: OPTI-MIST PLUS NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon, lote 7.; parque ind. del norte; reynosa, tamaulipas 88736 ; MX 88736
• Manufacturer (Section G): CONVATEC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5150102
• MDR Text Key: 28252367
• Report Number: 9680866-2015-00101
• 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,u
• Reporter Occupation: Nurse
• Type of Report: Followup,Followup,Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2016
• 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