MAUDE Adverse Event Report: UNOMEDICAL S. A. DE C.V UNO OPTIMIST NEB KIT PED; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 86-777-E

Device Problem Infusion or Flow Problem (2964)

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

Event Date 08/26/2015

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.No additional information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Reported to the fda on september 23, 2015.(b)(4).

Event Description

It was reported that prior to use on a patient, the nebulizer device was not misting when the nebulizer was connected to the oxygen.The issue was noticed immediately and the device was replaced with a new nebulizer that worked without any issues.

Manufacturer Narrative

Additional information: a quality investigation was performed to include a batch review.There were no discrepancies found during the batch review.Although there is not enough information to conclude the product did not meet specification and perform as intended, a previous investigation is applicable for the type of nebulizer issues reported in the current complaint.This previous investigation is still ongoing; therefore, this complaint will remain open until completion of the investigation.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

Previous investigation leveraged for this complaint 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.

• Brand Name: UNO OPTIMIST NEB KIT PED
• 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: 5097226
• MDR Text Key: 26553493
• Report Number: 9680866-2015-00079
• 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: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• 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: 86-777-E
• Device Lot Number: 108709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• 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