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

Model Number 3106-E

Device Problems Hole In Material (1293); Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Manufacturer Narrative

Expiration date: 08/2018.Manufacture date: 08/2013.Based on the available information, this event is deemed to be a reportable malfunction.(b)(6) 2016: no previous investigations are available to leverage.Detailed review of batch records for product and lot showed no discrepancies (including non-conformances/deviations).The evaluation of two (2) returned samples indicated that the reservoir bags had cuts/tears on them.The type of cuts/tears indicates that it could be caused during manipulation of devices in their use.It is highly unlikely that it could be a failure attributed to the manufacturing process.Based on the investigation results, it can be considered as an isolated quality issue that does not require any additional action.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.No additional details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).Note: this complaint issue occurred in four (4) separate cases.Separate 3500a forms have been completed for the cases.

Event Description

Complaint received from a distributor reporting issues with the oxygen reservoir on the product.Reporter stated "there are four (4) defective items, plastic balloon where it inflates has holes and oxygen escapes." there were no reports of patient use or patient harm.No further details were provided by the reporter.

• Brand Name: OXYGEN MASK NON-REBR ADLT
• 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: 5484744
• MDR Text Key: 39844190
• Report Number: 9680866-2016-00068
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3106-E
• Device Lot Number: 13-32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• 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