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

Model Number 3773MM

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

It was reported the nebulizer didn't operate when powered on during pretesting.The nebulizer allegedly "made noise" but did not produce an aerosol steam.As a result, the device was not used on the pt.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There were no reports of the pt being harmed as a result of this malfunction.Should add'l info become available, a f/u report will be submitted.

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.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 investigated and 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.(b)(4).

Manufacturer Narrative

A quality complaint investigation was performed.Six individual nebulizers with six labels of product 3773mm, and lot number 105415 were received on may 18, 2015.Labels were attached to initial complaint form dated on 04/28/2015.Returned nebulizers are the nebulizer of product 3773mm.Samples were tested to measure the aerosol output (aerosol steam get out) as per specification.Nebulizers generate the aerosol steam, but all samples did not meet 1.5 mg.Aerosol output requirements when operated.Samples marked as 1 and 3 did not meet the minimum aerosol output requirement.Samples were visually inspected to identify any visual characteristics that are not according to specification.The only observed characteristic was the orifice of nebulizer bottom not completely circular and there is a very small flash around the orifice.Orifice of nebulizer cup was measured and all samples met dimensions specified as in the current specification.The product (nebulizer) generates aerosol steam as it should, but the amount of aerosol output is not according to specification when operated at the lower flow rate (6 1/min).Additionally, two samples failed to meet requirement when operated at higher flow rate (10 1/min).Investigation performed by quality department of the manufacturing site indicated that product failed to meet the minimum aerosol output (1.5 ml) requirement specified in convatec test procedure.No previous investigations are available to leverage.After review of the returned product and detailed batch review, a discrepancy (minimum aerosol output below specification) was found.This warrants further action and a non-conformance will be opened.The complaint will remain in open status until completion of the corrective/preventive action.There are five (5) cases associated with this product; therefore a separate fda form 3500a has been generated to address the other four (4) cases.This is record 4 of 5 to capture the reported issue of does not produce an aerosol steam.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 june 01, 2015.

• Brand Name: OPTI-MIST PLUS MASK KIT, NEBULIZER WITH AEROSO
• 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 Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4768475
• MDR Text Key: 15231667
• Report Number: 9680866-2015-00033
• 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
• Report Date: 04/28/2015

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: 07/01/2019
• Device Model Number: 3773MM
• Device Lot Number: 105415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: 04/15/2016; 04/15/2016
• Supplement Dates FDA Received: 06/02/2015; 05/13/2016
• 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