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

Model Number 9108MM

Device Problem Material Rupture (1546)

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

Event Type  malfunction  

Manufacturer Narrative

Expiration date: 06/01/2019.Device/mfr date: 06/01/2014.Based on the available information, this event is deemed to be a reportable malfunction.No patient harm was reported.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).A total of two cases associated with this complaint.

Event Description

Complaint reporting, "for almost all masks the oxygen tube is tearing and falls off.Therefore the patient is not receiving oxygen anymore and could suffocate." no further information was provided.

Manufacturer Narrative

Product sample received.It was confirmed that the product samples were: (5) oxygen therapy, high concentration oxygen masks, non-rebreathing mask, adult, standard connector.Product was unused and could not determine malfunction from visual inspection.Product stored until further notice.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

This supplemental report is being submitted to correct the mfr report# for follow-up report#01 to 9680866-2016-00091, which was transcribed incorrectly during submission on january 19, 2017 in error.The last three (3) product monitoring reviews (pmrs) were reviewed and none of the affected product codes have illustrated any trends for product category or any malfunction or any harm.More specifically, there were no trends observed for the oxygen masks.Complaints spanning from october 27, 2014 to october 27, 2016 (2 years) were reviewed as it related to reports for the oxygen therapy products.A total of twenty-eight (28) complaints were reported.No trends were observed.However, there was one (1) non-conformance opened to investigate reports of tubing disconnecting from the oxygen therapy masks from various lot numbers.The non-conformance identified possible root causes as: inadequate assembly work instructions, and inadequate solvent dispenser.Corrective actions were implemented to correct the solvent gluing of the tubing to the masks by december, 2015.After review, this complaint has a batch that was made prior to corrective actions for the disconnecting tubing.No complaints after the corrective actions have been received for the affected products.No further action is required for investigation of this complaint.This issue will be monitored through the post market product monitoring review process.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 february 23, 2017.

• Brand Name: NON-REBREATHING OXYGEN MASKS
• 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 Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5984638
• MDR Text Key: 55879773
• Report Number: 9680866-2016-00091
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9108MM
• Device Lot Number: 104848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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