MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OXYGEN MASKS, ELONGATED (UNDER CHIN), ADULT; MASK, OXYGEN, NON-REBREATHING

Model Number 104-E

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There was no patient involvement.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.Note: there were five (5) devices involved in this complaint.A separate fda form 3500a or its electronic equivalent has been submitted for each device.(b)(4).

Event Description

It was reported the complainant performed tension testing on five oxygen masks residing in their factory storage.They reported that the tubes came off of the oxygen masks when a force between 2.2kg-3.8kg was applied.In addition, the complainant reported it appeared the tube had glue on it but had not been glued properly to the connection point.There was no patient involvement.

Manufacturer Narrative

A batch review was conducted and no discrepancies were found.There is no previous investigation available to leverage.Samples from current production lot number 104-e were checked and tested.All samples met retention requirement of 10 pounds between tube adapter and mask connector.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 at this time.A returned sample was expected, but not received.The investigation will be re-opened upon receipt of the complaint sample.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

Additional information: a sample was received and disconnection testing performed.The tube was assembled to the mask connector without applying glue and disconnected applying a force of 5.67 pounds.Then the tube was assembled again applying glue and disconnected applying force of 8.75 pounds.Based on the results the complaint sample did not meet specifications.A nonconformance was opened and this complaint will remain open until the completion of the investigation.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: OXYGEN MASKS, ELONGATED (UNDER CHIN), ADULT
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon, lote 7; marque ind. del norte; reynosa, tamaulipas 88736 ; MX 88736
• Manufacturer (Section G): CONVATEC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5147737
• MDR Text Key: 28142708
• Report Number: 9680866-2015-00087
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 09/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: 104-E
• Device Lot Number: 112530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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