MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OXYGEN AND AEROSOL THERAPY; MASK, OXYGEN, NON-REBREATHING

Model Number 3106-E

Device Problem Loose or Intermittent Connection (1371)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

It was reported that an oxygen mask had a loose connection where the oxygen tubing connects to the mask.The product was not used on any patient.

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.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 december 5, 2014.

Manufacturer Narrative

Additional information was received on december 08, 2014 confirming that the masks were not used on the patient.The original mask was discarded and the second mask will be returned.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

A quality investigation was performed.Returned complaint sample met visual requirements; however it does not meet functional (10 pounds retention) requirements.Tube disconnected from the mask connector to a force of 3 pounds.Then the tube was assembled again and then tested.It met 10 pounds retention requirements.A capa was created to address the disconnection of oxygen tube from the mask was checked and it was found that implemented actions applied to all products manufactured on july 30, 2014 and on.Product involved in the current complaint was manufactured prior to july 30, 2014; therefore no new action is recommended.The possibility of inadequate solvent application, if any, has been fixed and it includes the product 3106-e manufactured after july 30, 2014.The probable root cause was an inadequate application of solvent to join the tube to the mask connector.An investigation for this complaint issue was previously performed and is still valid.No additional corrective action has been identified as a result of this analysis.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

Corrected information for a query that was performed on february 17, 2015 and not reported on mdr manufacturer report number: 9680866-2014-00042 submitted on february 19, 2015.A complaint query was generated to capture all complaints with this reported issue from (b)(6) 2014 to (b)(6) 2015.The results of the query identified a total of 13 complaints for the reported connection issue.Of these complaints, 2 were identified as being associated with model (icc code) 3106-e.The lot number was not provided for this complaint and a sample was not returned; therefore, a full investigation could not be performed.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 october 21, 2015.

• Brand Name: OXYGEN AND AEROSOL THERAPY
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• 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 (Section G): CONVATEC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4344925
• MDR Text Key: 17998489
• Report Number: 9680866-2014-00042
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: 3106-E
• Device Lot Number: 104902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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