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

Model Number 1638-00

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.It is unknown if device was used on a patient.A quality investigation was performed.The actual complaint sample was not received for evaluation.However, a video that was provided by the customer was examined which revealed the discrepancy of liquid drops in the nebulizer product.The nebulizer was observed in the video to deliver aerosol steam together with liquid drops.Review of the batch records indicated that the product was manufactured according to specification and no discrepancies were observed during manufacturing.An nonconformance investigation has been opened.This complaint investigation will remain open until it is completed.Additional patient/event details have been requested.However, no further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported and depicted in a video that the nebulizer produced "large drops of liquid and failed to nebulize".

• Brand Name: UNO MULTIANGLE 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 (Section G): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5125154
• MDR Text Key: 27420091
• Report Number: 9680866-2015-00081
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K791536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Report Date: 09/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2019
• Device Model Number: 1638-00
• Device Lot Number: 106755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2015
• 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: Unknown
• Patient Sequence Number: 1