MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OPTI MIST NEBULIZER PLUS, W/ ADULT MASK, TUBING; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number LM-86-774

Device Problem Infusion or Flow Problem (2964)

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

Event Date 06/08/2015

Event Type  malfunction  

Event Description

The complainant reports the opti-mist nebulizer plus did not nebulize.

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 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.Reported to the fda on (b)(6) 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).

Manufacturer Narrative

Additional information was received to clarify complaint details.The role of the complainant is "unknown." pictures of the device have been provided.When the customer connected the device, he noticed that the micro nebulizer did not work very well.The nebulizer was connected but not to the patient.The 2 affected devices were not used on the patient.All patient info is not applicable since the device was not used on a patient.It is unknown if a new nebulizer was used from the same unomedical lot, a different unomedical lot or another brand of device.It was clarified that one nebulizer was affected for this case.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 11, 2015.

Manufacturer Narrative

A quality complaint investigation was performed.A complaint sample was expected but not received to assist with the investigation.Complaint investigation will be updated if the complaint sample is returned.A corrective/preventive action event was created to investigate confirmed nebulizer issues on previous complaints report on april, 2015 for icc code 3773mm.Icc code lm-86-774 (or lm-86-772) involved in the current complaint is manufactured with same nebulizer of icc code 3773mm where the previous issue was reported.Investigation performed by quality department of the manufacturing site based on the examination of batch records indicated that product was manufactured according to specification.No discrepancies (includes non-conformances/deviations) were found.Though there is not enough information to conclude the product did not meet specification and perform as intended, the previous investigation is applicable for the type of nebulizer issues reported in the current complaint.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 september 09, 2015.

• Brand Name: OPTI MIST NEBULIZER PLUS, W/ ADULT MASK, TUBING
• 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 avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4890913
• MDR Text Key: 6067914
• Report Number: 9680866-2015-00041
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K791536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,foreign,other
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/08/2015

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 Expiration Date: 01/01/2020
• Device Model Number: LM-86-774
• Device Lot Number: 108968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 06/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/11/2015; 09/09/2015; 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1