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

Model Number 86-775E

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

Expiration date: 06/2020.Based on the available information, this event is deemed to be a reportable malfunction.A return sample was not available for evaluation; therefore we could not confirm a discrepancy in the product.Current production samples are meeting the specification requirements and the detailed review of batch records for the product indicated that no discrepancies (includes non-conformances/deviations), were observed during manufacturing.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.Additional patient/event information was requested but not received at the time of this report.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

A distributor reported that the end of the tubing opening of the opti-mist clear nebulizer kit was too large to stay attached to the machine.It is unknown if the device was used for a patient.

• Brand Name: OPTI-MIST CLEAR NEBULIZER, KIT
• 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: 5503687
• MDR Text Key: 40410336
• Report Number: 9680866-2016-00071
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86-775E
• Device Lot Number: 1111883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2015
• 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