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

Model Number 3773MM

Device Problem Infusion or Flow Problem (2964)

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

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

Mfr date: 07/2014.Based on the available information, this event is deemed a reportable malfunction.There were no reports of patient harm as a result of the malfunction.A complaint sample was not received for evaluation; however, a batch record review was performed for the lot number provided.The review of the batch records indicated that the product was manufactured according to specification and no discrepancies were observed during the batch manufacturing.Previously, a non-conformance was raised to investigate this issue based on past complaints.The previous complaint investigation results indicated that current production met the specification requirements.A corrective action preventive action plan was initiated to further investigate and correct the non-conformance.The corrective action preventive action investigation found the root cause was a reduction in diameter of the flat jet nebulizer.The flat jet nebulizer was produced on an old injection machine which did not have an alarm to detect and prevent variations in the process and/or output.Further, the inspection process for the product was reviewed.Additional steps to improve detection of failures or variations in the equipment and process were incorporated into the inspection process.Finally, improved molding maintenance processes and revalidation of the molding process were completed.The corrective action preventive action plan has been closed.No further information was available at the time of this report.Should additional information become available, a follow-up report will be submitted.Note: forty-eight (48) cases are associated with this complaint.Separate fda 3500a forms have been completed for the associated cases.(b)(4).

Event Description

It was reported that during use on a patient, the mask did not "nebulize" when the oxygen was turned on.The mask was removed and a new device was used.There was no adverse impact to the patient as a result of the defective device.It was reported that during use on a patient, the mask did not "nebulize" when the oxygen was turned on.The mask was removed and a new device was used.There was no adverse impact to the patient as a result of the defective device.

• 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 Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5358363
• MDR Text Key: 35623415
• Report Number: 9680866-2016-00020
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• 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?: No
• Date Manufacturer Received: 12/14/2015
• 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