MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. UNO OPTIMIST+ NEB KIT (50)

Model Number 3773MM

Device Problem Disconnection (1171)

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

Event Date 06/12/2015

Event Type  malfunction  

Event Description

The complainant reports a (b)(6) female was admitted to the er with a respiratory rate in the 90's, receiving 15 liters of oxygen per minute via a non-rebreathing oxygen mask and had a pulse oximetry reading of 93%.It is further reported the patient was examined by a doctor twice and was diagnosed with pseudocroup, and asthmatic bronchitis and was prescribed a ventolin treatment to be delivered using the opti-mist plus nebulizer (opti-mist plus).It is further reported the first opti-mist plus sounded "very strange", due to the medication not nebulizing the oxygen flowmeter was increased to 4 liters per minute which resulted in the oxygen tubing to disconnect from the nebulizer.The complainant adds this nebulizer also didn't ''atomize' so the opti-mist plus was changed to another opti-mist plus.This opti-plus also didn't 'atomize' the medication and the oxygen tubing detached from the nebulizer connection.At this time a third opti-mist was placed on the patient which also didn't 'atomize', the oxygen tubing again detached from the nebulizer connection.A fourth opti-mist was placed.For each occurrence the oxygen tubing detached when the oxygen flowmeter was increased to 6 to 8 liters of oxygen per minute.The complainant also states it is unknown the precise liter per minute at which the oxygen tubing detached.It was reported a mask from another company worked and the patient was able to receive treatment.

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 patient/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.This complaint involves four devices, therefore a separate fda form 3500a will be drafted for each device.

Manufacturer Narrative

Additional information was received on july 28, 2015.Returned product was received at the manufacturing site on july 16, 2015.A quality complaint investigation was performed on (b)(6) 2015.One used sample was returned to assist with the investigation.The investigation performed by quality department of the manufacturing site indicated that product met the specification requirements.Reported disconnection could not be replicated on the returned sample.A functional test was performed to try to reproduce the disconnection of the tube.The tube did not disconnect from different air flow rates from 4 1/min to 10 1/min.No previous investigations are available to leverage.After review of the returned product and detailed batch review, no discrepancies were found.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will continue to monitor for product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to fda on august 03, 2015.

• Brand Name: UNO OPTIMIST+ NEB KIT (50)
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon secc. 4; lote 7, parque ind. del norte; reynosa, tams. 88736 ; MX 88736
• Manufacturer Contact: matthew walenciak ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4911751
• MDR Text Key: 6829872
• Report Number: 9680866-2015-00056
• 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: Other,Foreign,Health Professional,User Facility,foreign,health pr
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• 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?: Yes
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• 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
• Patient Age: 15 YR