MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. ADULT HIGH CONCENTRATION REBREATHER , OXYGEN MASK; MASK, OXYGEN, NON-REBREATHING

Model Number 104-E

Device Problem Detachment Of Device Component (1104)

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

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.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.Expiration date: 01/2020.Device manufacture date: 01/2015.(b)(4).

Event Description

It was reported that the oxygen tubing disconnected from the mask connectors while in use on the patient.This occurred with an unknown number of devices.There were no adverse impacts to the patients.No additional information was provided.

Manufacturer Narrative

Additional information: a quality investigation was conducted to include a batch review and testing of retention samples of 104-e and no discrepancies were noted.A prior capa was leveraged for this complaint and has concluded that possible root causes for disconnection could be attributed to poor application of solvent that join the tube to mask connector and the inconsistency of manufacturing operators to follow assembly work instructions.Corrective action has been implemented.This complaint will be closed without further action.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 january 13, 2016 (b)(4).

• Brand Name: ADULT HIGH CONCENTRATION REBREATHER , OXYGEN MASK
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• 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: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5265261
• MDR Text Key: 32660123
• Report Number: 9680866-2015-00113
• 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: Initial,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 104-E
• Device Lot Number: 108658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2015
• 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: Initial
• Patient Sequence Number: 1